COMFORTCAINE- lidocaine hcl gel

Comfortcaine by

Drug Labeling and Warnings

Comfortcaine by is a Otc medication manufactured, distributed, or labeled by QS Key West Aloe, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredients

Lidocaine HCL 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 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, Disodium EDTA, Sodium Hydroxide, Caprylyl Glycol, Methylisothiazolinone, FD&C 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

INGREDIENTS AND APPEARANCE

COMFORTCAINE 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65008-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65008-005-04	1 in 1 CARTON	03/27/2017
1		113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/12/2004

Labeler - QS Key West Aloe, LLC (969600555)