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NDC 15127-0871-43 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 Select Brand Distributors. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	15127-0871
Product ID	15127-871_0c3f3bd6-5987-4d48-88ca-8c28549c38e8
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	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	Select Brand Distributors
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 15127-0871-43 (15127087143)

Pricing Information	N/A
NDC Package Code	15127-871-43
Billing NDC	15127087143
Package	473 mL in 1 BOTTLE, PLASTIC (15127-871-43)
Marketing Start Date	2011-09-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 56b50699-f4fd-48a8-9bad-91a6d7e69a38 Details

Active ingredient

Hydrogen peroxide (stabilized) 3%

Purpose

First aid antiseptic

Oral debriding agent

Use

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

in the eyes or apply over large areas of 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

First aid antiseptic:
clean the affected area
apply 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 under 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 ingredient

purified water

SPL UNCLASSIFIED SECTION

Distributed by: Select Brand Distributors, Pine Bluff, AR 71603 USA

AC (870) 535-3635

principal display panel

Select Brand

the lower price name brand

Topical Solution U.S.P.

HYDROGEN PEROXIDE

FIRST AID ANTISEPTIC

ORAL DEBRIDING AGENT

For treatment of minor cuts & abrasions

For use as a gargle or rinse

Pharmacist Recommended

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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

16 FL OZ (473 mL)

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE

hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15127-871
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:15127-871-34	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2011
2	NDC:15127-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2011
3	NDC:15127-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/21/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/21/2011

Labeler - Select Brand Distributors (012578514)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(15127-871)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		088520668	manufacture(15127-871)

Revised: 4/2022

Document Id: 0c3f3bd6-5987-4d48-88ca-8c28549c38e8

Set id: 56b50699-f4fd-48a8-9bad-91a6d7e69a38

Version: 9

Effective Time: 20220420