Search by Drug Name or NDC

NDC 69103-5400-00 Hydrogen Peroxide 30 mL/L Details

Hydrogen Peroxide 30 mL/L

Hydrogen Peroxide is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Provision Medical. The primary component is HYDROGEN PEROXIDE.

Product Information

NDC	69103-5400
Product ID	69103-5400_718d361e-84ee-4293-8100-bb626762fa73
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	SPRAY
Route	TOPICAL
Active Ingredient Strength	30
Active Ingredient Units	mL/L
Substance Name	HYDROGEN PEROXIDE
Labeler Name	Provision Medical
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 69103-5400-00 (69103540000)

Pricing Information	N/A
NDC Package Code	69103-5400-0
Billing NDC	69103540000
Package	.0591 L in 1 BOTTLE, SPRAY (69103-5400-0)
Marketing Start Date	2022-07-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d99611e2-1079-4b78-96cd-4a1be87d9e6d Details

Active Ingredients

Hydrogen Peroxide 3.0%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only.

Do not use

near eyes or mucous membranes
on deep or puncture wounds, animal bites or serious burns

Keep out of reach of children

Caution

not for use on large areas of the body
if redness irritation, swelling or pain persists or increases, discontinue use and consult a physician.

Directions

spray over affected area
if bandaged, let dry first

Inactive Ingredients

purified water

Principal Display Panel – 2 fl. oz Bottle Label

The Provision

First Aid

Line™

Hydrogen

Peroxide Spray

First Aid to Help

Prevent Infection in

Minor Cuts, Scrapes

and Burns.

2 fl. oz. (59.1 ml)

Reorder no. 3503

Principal Display Panel – 2 fl. oz Bottle Label

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE

hydrogen peroxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69103-5400
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 mL in 1 L

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69103-5400-0	0.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/25/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/25/2022

Labeler - Provision Medical (036936831)

Name	Address	ID/FEI	Business Operations
Establishment
Safetec of America, Inc.		874965262	MANUFACTURE(69103-5400)

Revised: 11/2013

Document Id: 718d361e-84ee-4293-8100-bb626762fa73

Set id: d99611e2-1079-4b78-96cd-4a1be87d9e6d

Version: 1

Effective Time: 20131111