WALGREENS BURN RELIEF- lidocaine hydrochloride gel

Walgreens Burn relief by

Drug Labeling and Warnings

Walgreens Burn relief by is a Otc medication manufactured, distributed, or labeled by Walgreens, Weeks & Leo, Inc., weeks & Leo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl 4%......................................................................................................................... Topical analgesic

Uses

Temporarily relieves pain and itching due to: minor burns, sunburn, 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

Do not get into eyes

Stop use and ask doctor if

condition gets worse

symptoms last for more than 7 days

symptoms clear up and occur again within a few days

Keep out of reach of children

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

Burns Relief topical analgesic

Other Information

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

Inactive Ingredients

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

Prncipal Display Panel

Walgreens

Burn Gel LIDOCAINE HCl 4%

Compare to Alocane® active ingredient††

TOPICAL ANALGESIC

+ Vitamin E

Maximum Strength

+ Aloe

Fast pain & itch relief

Use on sunburns & minor burns

INGREDIENTS AND APPEARANCE

WALGREENS BURN RELIEF 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0290
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)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0290-25	1 in 1 CARTON	02/10/2018
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 not final	part348	02/10/2018

Labeler - Walgreens (008965063)

Registrant - Weeks & Leo, Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
weeks & Leo		005290028	manufacture(0363-0290)