HYDROGEN PEROXIDE  - hydrogen peroxide solution 
Worldwide Sales & Distribution Corp.

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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Quality Guaranteed Hydrogen Peroxide Solution

Drug Facts

Active ingredient
Hydrogen peroxide 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
  • 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

image of principal display panel

HYDROGEN PEROXIDE  
hydrogen peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE.3 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Steller Mercantile Pvt. Ltd.650493005manufacture

Revised: 8/2011
Document Id: e853c662-f640-481a-866c-35e1aebe957d
Set id: c6603207-82aa-4bcc-9ed7-b4208db83a3c
Version: 1
Effective Time: 20110825
 
Worldwide Sales & Distribution Corp.