HYDROGEN PEROXIDE- hydrogen peroxide solution 
Pioneer Associates

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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CAVALIER HYDROGEN PEROXIDE

Active ingredient (by volume)

Hydrogen Peroxide 3%

Purpose

first aid antiseptic/oral debriding agent

Uses

Warnings

For external use only

Do not use

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns

Stop use and ask a doctor if

Keep this and all drugs out of reach of children.

If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

first aid antiseptic:

oral debriding agent (oral rinse):

Other information

Inactive ingredient

Water

PRINCIPAL DISPLAY PANEL

CAVALIER HYDROGEN PEROXIDE SOLUTION

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)

hydrogen-peroxide

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53033-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53033-003-08100 mL in 1 BOTTLE, PLASTIC
2NDC:53033-003-01119 mL in 1 BOTTLE, PLASTIC
3NDC:53033-003-02178 mL in 1 BOTTLE, PLASTIC
4NDC:53033-003-09200 mL in 1 BOTTLE, PLASTIC
5NDC:53033-003-03237 mL in 1 BOTTLE, PLASTIC
6NDC:53033-003-10250 mL in 1 BOTTLE, PLASTIC
7NDC:53033-003-11266 mL in 1 BOTTLE, PLASTIC
8NDC:53033-003-04295 mL in 1 BOTTLE, PLASTIC
9NDC:53033-003-05354 mL in 1 BOTTLE, PLASTIC
10NDC:53033-003-06414 mL in 1 BOTTLE, PLASTIC
11NDC:53033-003-07473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/24/2012
Labeler - Pioneer Associates (012604336)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(53033-003)

Revised: 8/2012
Document Id: 001adbf8-50c8-44e1-9c78-4993c42c27b1
Set id: 3faa36a2-3d15-42a2-a03e-a76ef4e5d506
Version: 1
Effective Time: 20120824
 
Pioneer Associates