Label: COMFORTCAINE- lidocaine hcl gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 5, 2023

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  • ​Active Ingredients

    Lidocaine Hydrochloride (4% w/w)

  • ​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 the eyes.

    • ​Do not use​ ​in large quantities, particularly over raw surfaces or blistered areas.

    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

  • ​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, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Yellow No 5, FD&C Blue No 1.

  • Other Information

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

  • ​Questions or comments?

    1-800-445-2563

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    COMFORTCAINE 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65008-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65008-005-041 in 1 CARTON06/23/2023
    1113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/12/2004
    Labeler - QS Key West Aloe, LLC (969600555)
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