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NDC 50804-0871-43 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 Perrigo Direct, Inc.. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	50804-0871
Product ID	50804-871_19329e8a-da94-4d25-9d8e-e0fe3de9b9b2
Associated GPIs	92000020002010
GCN Sequence Number	009801
GCN Sequence Number Description	hydrogen peroxide SOLUTION 3 % MISCELL
HIC3	W8D
HIC3 Description	OXIDIZING AGENTS
GCN	45121
HICL Sequence Number	004267
HICL Sequence Number Description	HYDROGEN PEROXIDE
Brand/Generic	Generic
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	Perrigo Direct, 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 50804-0871-43 (50804087143)

Pricing Information	N/A
NDC Package Code	50804-871-43
Billing NDC	50804087143
Package	473 mL in 1 BOTTLE, PLASTIC (50804-871-43)
Marketing Start Date	1992-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2efcda54-b8b7-4266-89c0-7f686c7afdca 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 1 week

Ask a doctor before use if you have

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

Oral Debriding Agent (oral rinse):

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

Distrubuted by: Perrigo Direct, Inc

Peachtree City, GA 30269

www.PerrigoDirect.com

1-888-593-0593

Principal Display Panel

NDC 50804-871-45

DO NOT USE IF PRINTED SEAL UNDER

CAP IS BROKEN OR MISSING

GoodSense

Hydrogen

Peroxide

Topical Solution USP

First Aid Antiseptic
Oral Debriding Agent

32 FL OZ (1 QT) 946 mL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE

hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50804-871
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:50804-871-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/1992
2	NDC:50804-871-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/1992
3	NDC:50804-871-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/1992
4	NDC:50804-871-99	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/15/1992

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/15/1992

Labeler - Perrigo Direct, Inc. (076059836)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(50804-871)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(50804-871)

Revised: 10/2022

Document Id: 19329e8a-da94-4d25-9d8e-e0fe3de9b9b2

Set id: 2efcda54-b8b7-4266-89c0-7f686c7afdca

Version: 18

Effective Time: 20221007