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NDC 00363-0290-25 Walgreens Burn relief 4 g/100g Details

Walgreens Burn relief 4 g/100g

Walgreens Burn relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreens. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	00363-0290
Product ID	0363-0290_8875197e-6107-07d4-e053-2995a90a078b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Walgreens Burn relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Walgreens
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0290-25 (00363029025)

Pricing Information	N/A
NDC Package Code	0363-0290-25
Billing NDC	00363029025
Package	1 TUBE in 1 CARTON (0363-0290-25) / 74 g in 1 TUBE
Marketing Start Date	2018-02-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 887566b9-93cf-0c75-e053-2a95a90a30e2 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/10/2018

Labeler - Walgreens (008965063)

Registrant - Weeks & Leo, Inc. (005290028)

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

Revised: 5/2019

Document Id: 8875197e-6107-07d4-e053-2995a90a078b

Set id: 887566b9-93cf-0c75-e053-2a95a90a30e2

Version: 1

Effective Time: 20190509