DIVAS - hydrogen peroxide liquid 
JMD All Star Impex Inc

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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Drug Facts

Active Ingredient
Hydrogen peroxide 3%

Purpose
First aid antiseptic/oral debriding agent

Uses
first aid to help prevent risk of infection in minor cuts ,scrapes and burns
• aids 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 consult 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
In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately

Directions
First aid antiseptic                                                                                                 oral debriding agent (oral rinse)
•clean affected area                                                                                               Adults and children 2 years and over
•apply a small amount of this product on the affected area 1-3 times a day                 • mix with an equal amount of water
• may be covered with a sterile bandage                                                                   • swish around in the mouth over affected area for at least 1 minute then spit out
                                                                                                                             • use up to 4  times daily after meals and at
                                                                                                                               bedtime or as suggested by a doctor or dentist
•let dry first before using bandage

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

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

Inactive ingredients
purified water

Package Label
image of package label


DIVAS 
hydrogen peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51444-004
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:51444-004-73473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33307/26/2010
Labeler - JMD All Star Impex Inc (962316662)
Establishment
NameAddressID/FEIBusiness Operations
Steller Mercantile Pvt.Ltd.650493005manufacture

Revised: 7/2010
Document Id: 3e525fe4-9f5e-43d6-aef2-6bc5d4421bda
Set id: c8c6609f-cc45-4bf1-aa18-22ead184cc79
Version: 1
Effective Time: 20100708
 
JMD All Star Impex Inc