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NDC 79903-0037-34 Sunburn Relief 0.5 g/100g Details

Sunburn Relief 0.5 g/100g

Sunburn Relief is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by WALMART INC.. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	79903-0037
Product ID	79903-037_eb2a46e0-74ec-4ed5-a383-d0a3a0fb73c7
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	Sunburn Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCl 0.5%
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.5
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	WALMART INC.
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 79903-0037-34 (79903003734)

Pricing Information	N/A
NDC Package Code	79903-037-34
Billing NDC	79903003734
Package	226 g in 1 BOTTLE, PLASTIC (79903-037-34)
Marketing Start Date	2020-12-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1eef58d3-7671-48f6-b4c4-4b83eae9d197 Details

Active ingredient

Lidocaine HCl 0.5%

Purpose

External analgesic

Uses

for the temporary relief of pain and itching associated with

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

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or 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 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

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5

SPL UNCLASSIFIED SECTION

Questions? 1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY Walmart Inc., Bentonville, AR 72716

*This product is not manufactured or distributed by Bayer Healthcare,

LLC, owner of the registered trademark Solarcaine

Cool Aloe Burn Relief Formula.

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

Principal Display Panel

NDC 79903-037-34

EquateTM

Compare to Solarcaine Cool Aloe Burn Relief Formula active ingredient*

Burn

Relief Gel

WITH LIDOCAINE

Pain Relieving Gel

with Aloe

Empty & Replace Cap

PLASTIC BOTTLE

how2recycle.info

Relief from:

sunburn
Cuts & scrapes
Insect bites

Moisturizer

NET WT 8 OZ (226g)

INGREDIENTS AND APPEARANCE

SUNBURN RELIEF

lidocaine hcl 0.5% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:79903-037
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:79903-037-34	226 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/23/2020

Labeler - WALMART INC. (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(79903-037)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(79903-037)

Revised: 10/2022

Document Id: eb2a46e0-74ec-4ed5-a383-d0a3a0fb73c7

Set id: 1eef58d3-7671-48f6-b4c4-4b83eae9d197

Version: 5

Effective Time: 20221004

Search by Drug Name or NDC

NDC 79903-0037-34 Sunburn Relief 0.5 g/100g Details

Sunburn Relief 0.5 g/100g

Product Information

Package

Package Images

NDC 79903-0037-34 (79903003734)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 1eef58d3-7671-48f6-b4c4-4b83eae9d197 Details

Active ingredient

Purpose

Uses

Warnings

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Inactive ingredients

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Principal Display Panel

INGREDIENTS AND APPEARANCE

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