CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING- lidocaine hcl gel

CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving by

Drug Labeling and Warnings

CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lidocaine 0.5% (as Lidocaine HCl)

Purpose

External Analgesic

Uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites & minor skin irritations.

Warnings

For external use only

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

When using this product

• avoid contact with eyes.. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptomes clear up and occur again within a few days.

Keep out of reach of children.

• If swallowed, seek medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: ask a doctor.

Other information

May stain some fabrics.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Benzyl Alcohol, Blue 1, Carbomer, Isoceteth-20, Phenoxyethanol, Tetrasodium EDTA, Triethanolamine.

Label

INGREDIENTS AND APPEARANCE

CVS HEALTH SUNBURN RELIEF COOLING LIDOCAINE 0.5 PAIN-RELIEVING 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
SULISOBENZONE (UNII: 1W6L629B4K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
EDETATE SODIUM (UNII: MP1J8420LU)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
ISOCETETH-20 (UNII: O020065R7Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-022-15	170 g in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2018
2	NDC: 51316-022-20	567 g in 1 BOTTLE; Type 0: Not a Combination Product	10/05/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/05/2018

Labeler - CVS Pharmacy (062312574)