DIVAS- hydrogen peroxide liquid

Divas by

Drug Labeling and Warnings

Divas by is a Otc medication manufactured, distributed, or labeled by JMD All Star Impex Inc, Steller Mercantile Pvt.Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Hydrogen peroxide 3%

PURPOSE

Purpose
First aid antiseptic/oral debriding agent

INDICATIONS & USAGE

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

Warnings
For external use only

Do not use
  in the eyes or apply over large areas of the body  more than one week

ASK DOCTOR

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

STOP USE

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

Keep out of reach of children
In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately

DOSAGE & ADMINISTRATION

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

SPL UNCLASSIFIED SECTION

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 INGREDIENT

Inactive ingredients
purified water

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

DIVAS 
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51444-004
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: 51444-004-73	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	07/26/2010

Labeler - JMD All Star Impex Inc (962316662)

Establishment
Name	Address	ID/FEI	Business Operations
Steller Mercantile Pvt.Ltd.		650493005	manufacture