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Comfortcaine by QS Key West Aloe, LLC

Medically reviewed on March 27, 2017

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 40mg in 1g
Labeler: QS Key West Aloe, LLC
NDC Code: 65008-005

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.

Comfortcaine

​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

COMFORTCAINE 
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65008-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
WATER 
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
SODIUM HYDROXIDE 
CAPRYLYL GLYCOL 
METHYLISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:65008-005-041 BOTTLE, PLASTIC in 1 CARTON
1113 g in 1 BOTTLE, PLASTIC
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)

 
QS Key West Aloe, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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