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NDC 00363-0978-88 Walgreens Sunburn Relief 5 mg/g Details

Walgreens Sunburn Relief 5 mg/g

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

Product Information

NDC	00363-0978
Product ID	0363-0978_d4c98756-b7e1-f2fc-e053-2a95a90a7f5e
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	Lidocaine Hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	5
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	WALGREEN COMPANY
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 00363-0978-88 (00363097888)

Pricing Information	N/A
NDC Package Code	0363-0978-88
Billing NDC	00363097888
Package	227 g in 1 CAN (0363-0978-88)
Marketing Start Date	2021-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d4c9913d-fcac-4785-e053-2995a90a7917 Details

Active Ingredients

Lidocaine 0.5% (as Lidocaine HCl)

Purpose

Topical Analgesic

Uses

Temporary relieves pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, or , 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

keep out of eyes. Rinse with water to remove.
do not puncture or incinerate. Contents under pressure.
do not store at temperatures above 120°F.

Stop use and ask a doctor if

condition gets worse
symptoms last more than 7 days
symptoms clear up and occur again in a few days

Keep out of reach of children

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

Directions

Adults and Children 2 Years of Age andAolder; Spray onto affected area not more than 3 to 4 times daily. To apply to face, spray in palm of hand and gently apply.
Children Under 2 Years of Age: Ask a doctor.

Other information

may stain some fabrics

Inactive Ingredients

Water, Aloe Barbadensis Leaf Juice, Isoceteth-20, Tocophorol, Menthol, Carbomer, Tetrasodium EDTA, Benzophenone 4, Triethanolamine, Polysorbate 20, Benzyl Alcohol, Phenoxyethanol

INGREDIENTS AND APPEARANCE

WALGREENS SUNBURN RELIEF

lidocaine hydrochloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0978
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LEVOMENTHOL (UNII: BZ1R15MTK7)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOCETETH-20 (UNII: O020065R7Z)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
SULISOBENZONE (UNII: 1W6L629B4K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0363-0978-88	227 g in 1 CAN; Type 0: Not a Combination Product	02/24/2021
2	NDC:0363-0978-25	170 g in 1 CAN; Type 0: Not a Combination Product	04/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/24/2021

Labeler - WALGREEN COMPANY (008965063)

Revised: 1/2022

Document Id: d4c98756-b7e1-f2fc-e053-2a95a90a7f5e

Set id: d4c9913d-fcac-4785-e053-2995a90a7917

Version: 1

Effective Time: 20220104