BERKLEY JENSEN ANTISEPTIC- hydrogen peroxide liquid

Berkley Jensen by

Drug Labeling and Warnings

Berkley Jensen by is a Otc medication manufactured, distributed, or labeled by TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrogen peroxide 3%

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

For external use only.

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

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

stop use

Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

Ask doctor 

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

Do not use

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

DOSAGE & ADMINISTRATION

Directions For use as a 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. 
• For use as an oral debriding agent (oral rinse): 
• adults and children 2 years of age and over
• mix with an equal amount of water.
• swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow. 
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
• children under 12 years should be supervised in the use of this product. 
• children under 2 years of age: consult a dentist or doctor.

Other information

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

INACTIVE INGREDIENT

Inactive ingredient purified water

Packaging

INGREDIENTS AND APPEARANCE

BERKLEY JENSEN  ANTISEPTIC
hydrogen peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-028-95	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/23/2021

Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)

Establishment
Name	Address	ID/FEI	Business Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI		533120570	manufacture(76772-028)