Hydrogen Peroxide

Hydrogen Peroxide

Drug Labeling and Warnings

Drug Details

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HYDROGEN PEROXIDE- hydrogen peroxide solution 
Navajo Mfg. Co.

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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Hydrogen Peroxide

Drug Facts

Active Ingredient

Hydrogen Peroxide (stabilized 3%)

Purpose

First aid antiseptic/Oral debriding agent

Uses

  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aids in the removal of phlegm, mucous, or other secretions associated with occasional sore mouth

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:

  • clean the affected area
  • apply a small amount of product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

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

  • mix with an equal amount of water
  • swish around in the mouth over the affected area for at least 1 minute and then spit out
  • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
  • children under 12 years of age should be supervised in the use of this product
  • children under 2 years of age: consult a dentist or doctor

Other Information

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

Inactive Ingredient

Purified Water

Handy Solutions

Hydrogen Peroxide

3% USP Topical Solution

first aid antiseptic 

oral debriding agent

TAMPER EVIDENT CAP FOR YOUR PROTECTION.

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

4 FL OZ (118 mL)

image description

HYDROGEN PEROXIDE 
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67751-001
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: 67751-001-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/24/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2013
Labeler - Navajo Mfg. Co. (091917799)
Registrant - Hydrox Laboratories (025164302)
Establishment
NameAddressID/FEIBusiness Operations
Hydrox Laboratories025164302label(67751-001) , manufacture(67751-001) , pack(67751-001)

Revised: 2/2019
 
Navajo Mfg. Co.


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