Walgreens Burn Relief: Package Insert and Label Information

WALGREENS BURN RELIEF- lidocaine hydrochloride gel
Walgreens

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.

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

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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

Burn Gel .jpg
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WALGREENS BURN RELIEF
lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0290
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
PHENOXYETHANOL
CAPRYLYL GLYCOL
ALOE VERA LEAF
PROPANEDIOL
DIMETHYL ISOSORBIDE
WATER
CHLORPHENESIN
.ALPHA.-TOCOPHEROL ACETATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0290-25 1 TUBE in 1 CARTON contains a TUBE
1 74 g in 1 TUBE This package is contained within the CARTON (0363-0290-25)
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 Operations
weeks & Leo 005290028 manufacture (0363-0290)

Revised: 05/2019 Walgreens

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