Comfortcaine gel

Active ingredients

Lidocaine 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

Warnings

For external use only.

Avoid contact with eyes.

Do not use on damaged or broken skin.

Stop use and ask a doctor if

Rash or irritation occurs or if symptoms persist for more than 7 days.

Keep out of reach of children

If accidentally ingested contact a physician or Poison Control Center immediately.

Directions

Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Inactive ingredients:

Aloe Barbadensis Leaf Extract, Water, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Caprylyl Glycol, Methylisothiazolinone, FD&C Yellow No. 5, FD&C Blue No. 1

Other information

Store at room temperature 15-30C (59-86F)

Questions or comments?

1-800-445-2563

Ingredients and appearance - Product information

Comfortcaine gel- Lidocaine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 65008-001
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Lidocaine ( UNII: 98PI200987)( Lidocaine - UNII: 98PI200987 ) 40 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Aloe vera leaf ( UNII: ZY81Z83H0X)
Water ( UNII: 059QF0KO0R)
Carbomer interpolymer type b (allyl pentaerythritol crosslinked) ( UNII: 132584PQMO)
Edetate disodium ( UNII: 7FLD91C86K)
Sodium hydroxide ( UNII: 55X04QC32I)
Caprylyl glycol ( UNII: 00YIU5438U)
Methylisothiazolinone ( UNII: 229D0E1QFA)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - QS Key West Aloe, LLC( 969600555)

Package label.principal display panel