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 - 946 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 Type HUMAN OTC DRUG Item Code (Source) NDC:10565-001
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide 3 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10565-001-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993
2 NDC:10565-001-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993
3 NDC:10565-001-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993
4 NDC:10565-001-32 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993
5 NDC:10565-001-99 3800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/01/1993
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 09/01/1993
Labeler - Hydrox Laboratories (025164302)
Registrant - Hydrox Laboratories (025164302)
Establishment
Name Address ID/FEI Business Operations
Hydrox Laboratories 025164302 MANUFACTURE(10565-001) , label(10565-001) , pack(10565-001)

Revised: 11/2018
Document Id: cfb3677d-3f26-46d8-9406-d1e840535f1c
Set id: 6e5709b4-cc56-4768-b704-1d9b0e3efec7
Version: 5
Effective Time: 20181121
 
Hydrox Laboratories