HYDROGEN PEROXIDE- hydrogen peroxide solution 
Hydrox Laboratories

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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SOLUTION OF
HYDROGEN PEROXIDE
3% USP 10 VOLUME

Drug Facts

Active ingredient

Hydrogen Peroxide (stabilized) 3%

Purpose

First aid antiseptic/Oral debriding agent

Uses

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 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:

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

Other information

Keep tightly closed in a cool dark place. Do not shake bottle. Hold away from face when opening.

Inactive ingredient

Purified Water

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

OPTIMATES
HYDROX
CHEMICALS
TRADEMARK
SINCE 1913

Hydrox

NDC 10565-001-16

SOLUTION OF
HYDROGEN PEROXIDE
3% USP 10 VOLUME

3%

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

FIRST AID ANTISEPTIC
Made in USA

16 FL. OZ. (473 mL)peroxide

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-001
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:10565-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1993
2NDC:10565-001-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1993
3NDC:10565-001-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1993
4NDC:10565-001-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1993
5NDC:10565-001-993800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/1993
Labeler - Hydrox Laboratories (025164302)
Registrant - Hydrox Laboratories (025164302)
Establishment
NameAddressID/FEIBusiness Operations
Hydrox Laboratories025164302MANUFACTURE(10565-001) , label(10565-001) , pack(10565-001)

Revised: 11/2021
Document Id: 34b78d79-18dc-4e9c-8437-a1f6d9f8b82d
Set id: 6e5709b4-cc56-4768-b704-1d9b0e3efec7
Version: 8
Effective Time: 20211108
 
Hydrox Laboratories