Anesthetic, local (topical application route)

Brand Name

US Brand Name

Aloe Vesta 2-N-1 Protective

Aloe Vesta 2-N-1 Skin Conditioner

Analpram E

Aristocort A

Aveeno Anti-Itch

Avenova

Betadine

Biofreeze

Curasore

Emla

Exactacain

Frigiderm

Gebauer's Ethyl Chloride

LidAll

LidaMantle HC Relief

Lidoderm

Mycocide NS

Nupercainal

Pramegel

Prolida

Silvera

Solaraze

Solarcaine First Aid

Sting Kill

Synera

Ulcerease

Ultra Mide

Velma

Xylocaine

Canadian Brand Name

Baby Orajel Nighttime Formula

Bactine

Bactine First Aid

Bengay Ice Extra Strength

Clear Anti-Itch Lotion

Dermoplast Maximum Strength

Lanacane

Medicated Calamine Lotion With Pramoxine Hcl

Medicated Foot Powder

Myoflex Ice Cold Plus

Description

This medicine belongs to a group of medicines known as topical local anesthetics. Topical anesthetics are used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, and minor cuts and scratches.

Topical anesthetics deaden the nerve endings in the skin. They do not cause unconsciousness as do general anesthetics used for surgery.

Most topical anesthetics are available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

This product is available in the following dosage forms:

Solution
Cream
Spray
Pad
Gel/Jelly
Ointment
Patch, Extended Release
Lotion
Swab
Liquid
Soap

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Benzocaine may be absorbed through the skin of young children and cause unwanted effects. There is no specific information comparing use of other topical anesthetics in children with use in other age groups, but it is possible that they may also cause unwanted effects in young children. Check with your doctor before using any product that contains a topical anesthetic for a child younger than 2 years of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of topical anesthetics in the elderly with use in other age groups.

Pregnancy

Although studies on effects in pregnancy have not been done in humans, topical anesthetics have not been reported to cause problems in humans. Lidocaine has not been shown to cause birth defects or other problems in animal studies. Other topical anesthetics have not been studied in animals.

Breastfeeding

Topical anesthetics have not been reported to cause problems in nursing babies.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Dronedarone
Saquinavir
Vernakalant

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Alcuronium
Amifampridine
Amiodarone
Amprenavir
Arbutamine
Articaine
Atracurium
Benoxinate
Benzocaine
Benzyl Alcohol
Bretylium
Bupivacaine Liposome
Bupropion
Chloroprocaine
Cisatracurium
Cobicistat
Cocaine
Darunavir
Dasabuvir
Delavirdine
Dibucaine
Disopyramide
Dofetilide
Donepezil
Doxacurium
Dronedarone
Dyclonine
Encainide
Ethyl Chloride
Etidocaine
Etravirine
Fazadinium
Flecainide
Fosamprenavir
Fosphenytoin
Gallamine
Hexafluorenium
Hyaluronidase
Ibutilide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

For safe and effective use of this medicine:

Follow your doctor's instructions if this medicine was prescribed.
Follow the manufacturer's package directions if you are treating yourself.
Unless otherwise directed by your doctor, do not use this medicine on large areas, especially if the skin is broken or scraped. Also, do not use it more often than directed on the package label, or for more than a few days at a time. To do so may increase the chance of absorption through the skin and the chance of unwanted effects. This is especially important when benzocaine is used for children younger than 2 years of age.

This medicine should be used only for problems being treated by your doctor or conditions listed in the package directions. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Read the package label very carefully to see if the product contains any alcohol. Alcohol is flammable and can catch on fire. Do not use any product containing alcohol near a fire or open flame, or while smoking. Also, do not smoke after applying one of these products until it has completely dried.

If you are using this medicine on your face, be very careful not to get it in your eyes, mouth, or nose. If you are using an aerosol or spray form of this medicine, do not spray it directly on your face. Instead, use your hand or an applicator (for example, a sterile gauze pad or a cotton swab) to apply the medicine.

For patients using butamben:

Butamben may stain clothing and discolor hair. It may not be possible to remove the stains. To avoid this, do not touch your clothing or your hair while applying the medicine. Also, cover the treated area with a loose bandage after applying butamben, to protect your clothes.

To use lidocaine film-forming gel (e.g., DermaFlex):

First dry the area with a clean cloth or a piece of gauze. Then apply the medicine. The medicine should dry, forming a clear film, after about 1 minute.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For benzocaine and for benzocaine and menthol combination

For topical dosage forms (aerosol solution, cream, lotion, ointment, and spray solution):
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

For butamben

For topical dosage form (ointment):
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day as needed.
  - Children—Dose must be determined by your doctor.

For dibucaine

For topical cream dosage form :
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children up to 2 years of age—Dose must be determined by your doctor.
For topical ointment dosage form :
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a twenty-four-hour period is 30 grams, but much smaller amounts are usually enough.
  - Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7.5 grams in a twenty-four-hour period.
  - Children up to 2 years of age—Dose must be determined by your doctor.

For lidocaine

For topical dosage forms (aerosol solution, film-forming gel, jelly, ointment, and spray solution):
- For pain and itching caused by minor skin conditions:
  - Adults—Apply to the affected area three or four times a day as needed.
  - Children—Dose must be determined by your doctor.

For pramoxine and for pramoxine and menthol combination

For topical dosage forms (cream, gel, and lotion):
- For pain and itching caused by minor skin conditions:
  - Adults and children 2 years of age and older—Apply to the affected area three or four times a day as needed.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

For tetracaine and for tetracaine and menthol combination

For topical dosage forms (cream and ointment):
- For pain and itching caused by minor skin conditions:
  - Adults and teenagers—Apply to the affected area three or four times a day as needed. The largest amount that may be used in a twenty-four-hour period is 30 grams (a whole tube of the medicine), but much smaller amounts are usually enough
  - Children 2 years of age and older—Apply to the affected area three or four times a day as needed. Do not use more than 7 grams (about one-fourth of a tube of the medicine) in a twenty-four-hour period.
  - Children younger than 2 years of age—Dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Do not keep outdated medicine or medicine no longer needed.

Precautions

After applying this medicine to the skin of a child, watch the child carefully to make sure that he or she does not get any of the medicine into his or her mouth. Topical anesthetics can cause serious side effects, especially in children, if any of the medicine gets into the mouth or is swallowed.

Stop using this medicine and check with your doctor:

If your condition does not improve within 7 days, or if it gets worse
If the area you are treating becomes infected
If you notice a skin rash, burning, stinging, swelling, or any other sign of irritation that was not present when you began using this medicine
If you swallow any of the medicine

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Large swellings that look like hives on the skin or in the mouth or throat

Symptoms of too much medicine being absorbed by the body

Blurred or double vision
confusion
convulsions (seizures)
dizziness or lightheadedness
drowsiness
feeling hot, cold, or numb
headache
increased sweating
ringing or buzzing in the ears
shivering or trembling
slow or irregular heartbeat
troubled breathing
unusual anxiety, excitement, nervousness, or restlessness
unusual paleness
unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Burning, stinging, or tenderness not present before treatment
skin rash, redness, itching, or hives

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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