COMFORTCAINE- lidocaine hcl gel 
QS Key West Aloe, LLC

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.

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Comfortcaine

​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

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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)

Revised: 9/2023
Document Id: 2ea877b9-5363-4e2f-9d2d-0f669094f099
Set id: 831b7c11-e437-4e74-808e-c9c1eb8b82f6
Version: 4
Effective Time: 20230905
 
QS Key West Aloe, LLC