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NDC 49035-0871-43 Hydrogen Peroxide 30 mg/mL Details

Hydrogen Peroxide 30 mg/mL

Hydrogen Peroxide is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores, Inc.. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	49035-0871
Product ID	49035-871_e33e987c-8a00-406b-ad2d-e1a4b8b3b404
Associated GPIs	92000020002010
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	Hydrogen Peroxide
Proprietary Name Suffix	n/a
Non-Proprietary Name	HYDROGEN PEROXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	30
Active Ingredient Units	mg/mL
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Wal-Mart Stores, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49035-0871-43 (49035087143)

Pricing Information	N/A
NDC Package Code	49035-871-43
Billing NDC	49035087143
Package	473 mL in 1 BOTTLE, PLASTIC (49035-871-43)
Marketing Start Date	2017-07-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ebd02cd3-75cc-444b-8284-d28733a2855b Details

Active ingredient

Hydrogen peroxide (stablized) 3%

Purpose

First Aid Antiseptic

Oral debriding agent

Uses

first aid to help prevent the risk of infection in minor cuts, scrapes and burns
aids in the removal of phlegm, mucus, or other secretionsassociated with occasional sore mouth

Warnings

For external use only

Do not use

in the eyes or apply over large areas of the the body
longer than one week

Ask a doctor before use if you have

deep or puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

the condition persists or gets worse
sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash, or fever develops

Keep out of reach of children.

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

Directions

For First aid:

clean the affected area
spray a small amount of product on the affected area 1 to 3 times a day
may be covered with a sterile bandage
if bandaged, let dry first

Oral debriding agent: adults, children over 2 years of age:

mix with an equal amount of water
swish around in the mouth over the affected area for at least 1 minute, then spit out
use up to 4 times daily after meals and at bedtime
children under 12 years of age should be supervised in the use
children 2 years of age: consult a dentist, doctor

Other information

keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.

Inactive ingredients

purified water

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Pat. D675,101

principal display panel

Do not use if printed seal under cap is broken or missing

NDC 49035-871-43

Hydrogen Peroxide Topical Solution USP

first aid antiseptic

oral debriding agent

Made in the USA factory Certified

Use for:

For treatment of minor cuts and abrasions
For use as a gargle or rinse

Square bottles use less plastic than a similarly sized round bottle

Recyclable (if available in your area)

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE

hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-871
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	30 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49035-871-99	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/08/2019
2	NDC:49035-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2017
3	NDC:49035-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/09/2017

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(49035-871)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(49035-871)

Revised: 3/2022

Document Id: e33e987c-8a00-406b-ad2d-e1a4b8b3b404

Set id: ebd02cd3-75cc-444b-8284-d28733a2855b

Version: 11

Effective Time: 20220322