CVS MAXIMUM STRENGTH BURN- lidocaine hydrochloride 4% gel

CVS Maximum Strength Burn by

Drug Labeling and Warnings

CVS Maximum Strength Burn by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Weeks & Leo, Inc., weeks & Leo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine HCl 4%

INDICATIONS & USAGE

Temporarily relieves pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations

WARNINGS

For external use only

In large quantities, particularly over raw surfaces or blistered areas

Do not get into eyes

condition gets worse

symptoms last for more than 7 days

symptoms clear up and occur again within a few days

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
• children under 2 years: ask a doctor

PURPOSE

topical analgesic

Other Information

Store between 20 °C and 25 °C (68 °F and 77 °F)

INACTIVE INGREDIENT

Aloe barbadensis (aloe vera) leaf juice, caprylyl glycol, chlorphensin, dimethyl isosorbide, hydroxyethyl cellulose, phenoxyethanol, propanediol, purified water, vitamin E

QUESTIONS

call 515-276-1586

PRINCIPAL DISPLAY PANEL

CVS Health

Maximum Strength Burn Gel

Lidocaine HCl 4%

Topical Analgesic

• Use on sunburns & minor burns
• Past pain & itch relief
• Soothing aloe & vitamin E

INGREDIENTS AND APPEARANCE

CVS MAXIMUM STRENGTH BURN 
lidocaine hydrochloride 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-309-25	1 in 1 CARTON	01/01/2022
1		74 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2022

Labeler - CVS Pharmacy (062312574)

Registrant - Weeks & Leo, Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
weeks & Leo		005290028	manufacture(69842-309)