HYDROGEN PEROXIDE solution

Hydrogen Peroxide by

Drug Labeling and Warnings

Hydrogen Peroxide by is a Otc medication manufactured, distributed, or labeled by Pioneer Associates, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (by volume)

Hydrogen Peroxide 3%

PURPOSE

Purpose

first aid antiseptic/oral debriding agent

INDICATIONS & USAGE

Uses

• first aid to help prevent the 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

Do not use

• in the eyes or apply over large areas of the body
• longer than one week
• on deep or puncture wounds, animal bites or on serious burns

ASK DOCTOR

Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns

STOP USE

Stop use and ask a doctor if

• the condition persists or gets worse
• swelling, rash or fever develops
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children.

If swallowed, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

first aid antiseptic:

• clean affected area
• apply small amount of product on affected area 1-3 times a day
• 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 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

SPL UNCLASSIFIED SECTION

Other information

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

INACTIVE INGREDIENT

Inactive ingredient

Water

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

CAVALIER HYDROGEN PEROXIDE SOLUTION

FIRST AID ANTISEPTIC/ORAL DEBRIDING AGENT

16 FL.OZ (473 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROGEN PEROXIDE 
hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53033-003
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: 53033-003-08	100 mL in 1 BOTTLE, PLASTIC
2	NDC: 53033-003-01	119 mL in 1 BOTTLE, PLASTIC
3	NDC: 53033-003-02	178 mL in 1 BOTTLE, PLASTIC
4	NDC: 53033-003-09	200 mL in 1 BOTTLE, PLASTIC
5	NDC: 53033-003-03	237 mL in 1 BOTTLE, PLASTIC
6	NDC: 53033-003-10	250 mL in 1 BOTTLE, PLASTIC
7	NDC: 53033-003-11	266 mL in 1 BOTTLE, PLASTIC
8	NDC: 53033-003-04	295 mL in 1 BOTTLE, PLASTIC
9	NDC: 53033-003-05	354 mL in 1 BOTTLE, PLASTIC
10	NDC: 53033-003-06	414 mL in 1 BOTTLE, PLASTIC
11	NDC: 53033-003-07	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	part333A	08/24/2012

Labeler - Pioneer Associates (012604336)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(53033-003)