HYDROGEN PEROXIDE- hydrogen peroxide spray 
Provision Medical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 consult a physician

Keep out of reach of children.

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

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

Inactive ingredients

purified water

Principal Display Panel - Bottle Label

HYDROGEN
PEROXIDE

First Aid Treatment for Minor Cuts,
and Abrasions

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

Principal Display Panel - Bottle Label
HYDROGEN PEROXIDE 
hydrogen peroxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-3503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide30 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-3503-10.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/29/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-3503)

Revised: 8/2014
Document Id: 86bb7692-df50-43dc-8f6f-0d71d6139fd9
Set id: 239ba279-9ac2-4edc-8e0b-697e16951986
Version: 2
Effective Time: 20140829
 
Provision Medical