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NDC 37205-0871-45 Hydrogen Peroxide 3 kg/100L Details

Hydrogen Peroxide 3 kg/100L

Hydrogen Peroxide is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	37205-0871
Product ID	37205-871_02f5eff8-de96-44bb-88c9-bdb13c2d27d9
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	LOTION
Route	TOPICAL
Active Ingredient Strength	3
Active Ingredient Units	kg/100L
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Cardinal Health
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2022-12-31

Package

Package Images

NDC 37205-0871-45 (37205087145)

Pricing Information	N/A
NDC Package Code	37205-871-45
Billing NDC	37205087145
Package	.946 L in 1 BOTTLE, PLASTIC (37205-871-45)
Marketing Start Date	2012-05-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 219ba811-75cb-4a36-8df8-06c7b7303c2a Details

Active Ingredient

Hydrogen peroxide (stabilized) 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 secretions associated with occasional sore mouth

Warnings

For external use only

Do not use

•in eyes or apply over large areas of the body

•longer than 1 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

•irritation, pain or redness persists or worsens

•swelling, rash, or fever develops

Oral debriding agent (oral rinse): adults and children 2 years of age and over:

•mix with an 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

•children under 12 years of age should be supervised in the use of this product

•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

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

PRINCIPAL DISPLAY PANEL

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

NDC 32706-871-43

LEADER

Hydrogen Peroxide Topical Solution USP

First Aid Antiseptic

Oral Debriding Agent

16 FL OZ (1 PT) 473 mL

871.001/871AA

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE

hydrogen peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-871
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	3 kg in 100 L

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37205-871-43	.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012
2	NDC:37205-871-45	.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012
3	NDC:37205-871-34	.237 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/12/2012

Labeler - Cardinal Health (097537435)

Registrant - Vi-Jon Inc (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, Inc		790752542	manufacture(37205-871)

Revised: 12/2018

Document Id: 02f5eff8-de96-44bb-88c9-bdb13c2d27d9

Set id: 219ba811-75cb-4a36-8df8-06c7b7303c2a

Version: 5

Effective Time: 20181226