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NDC 00363-0966-15 Walgreens Sunburn Relief 5 mg/g Details

Walgreens Sunburn Relief 5 mg/g

Walgreens Sunburn Relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by WALGREEN COMPANY. The primary component is MENTHOL.

Product Information

NDC	00363-0966
Product ID	0363-0966_c8966b17-a8e1-79b3-e053-2a95a90af086
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 Sunburn Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	MENTHOL
Labeler Name	WALGREEN COMPANY
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00363-0966-15 (00363096615)

Pricing Information	N/A
NDC Package Code	0363-0966-15
Billing NDC	00363096615
Package	170 g in 1 TUBE (0363-0966-15)
Marketing Start Date	2017-09-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8967fba-6c28-494b-e053-2995a90acbba Details

Active Ingredients

Menthol 0.5%

Purpose

External Analgesic

Uses

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

Warnings

For External Use Only

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
symptoms 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 of age and older: Apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Ask a doctor.

Inactive Ingredients:

aloe barbadensis leaf juice, isoceteth-20, triethanolamine, carbomer, allantoin, benzophenone-4, tetrasodium EDTA, propylene glycol, methylparaben, propylparaben, diazolidinyl urea, blue 1, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS SUNBURN RELIEF

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0966
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOCETETH-20 (UNII: O020065R7Z)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0966-15	170 g in 1 TUBE; Type 0: Not a Combination Product	09/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/11/2017

Labeler - WALGREEN COMPANY (008965063)

Revised: 8/2021

Document Id: c8966b17-a8e1-79b3-e053-2a95a90af086

Set id: c8967fba-6c28-494b-e053-2995a90acbba

Version: 1

Effective Time: 20210802