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Hydrogen Peroxide by Worldwide Sales & Distribution Corp.

Medically reviewed on Aug 27, 2018

Dosage form: solution
Ingredients: HYDROGEN PEROXIDE .3kg in 100L
Labeler: Worldwide Sales & Distribution Corp.
NDC Code: 76384-007

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.

Quality Guaranteed Hydrogen Peroxide Solution

Drug Facts

Active ingredient
Hydrogen peroxide 3%

Purpose
First aid antiseptic
Oral debriding agent

Uses
  • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • aid in the removal of phlegm, mucus 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
  • more than one week

Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

Stop use and ask a doctor if
  • the condition persists or gets worse
  • sore mouth symptoms do not improve in a week
  • pain redness or irritation persists or if you develop fever, rash or swelling

Keep out of reach of children
If swallowed seek professional assistance or contact a poison control center immediately

Directions
First aid antiseptic
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•let dry first before using bandage

Oral debriding agent (oral rinse)
Adults and children 2 years of age and over:
• mix with 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 doctor or dentist

• children under 2 years of age: consult a dentist or doctor
• children under 12 years of age should be supervised in the use of this product

Other information
Keep tightly closed in a dark place at controlled room temperature
Do not shake bottle. Keep away from face when opening

Inactive ingredient
Purified water

Package Label

HYDROGEN PEROXIDE  
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-007
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE.3 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:76384-007-01.473 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/25/2011
Labeler - Worldwide Sales & Distribution Corp. (627014330)
Establishment
NameAddressID/FEIOperations
Steller Mercantile Pvt. Ltd.650493005manufacture

 
Worldwide Sales & Distribution Corp.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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