BERKLEY JENSEN ANTISEPTIC- isopropyl alcohol solution

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]

Active ingredient

Isopropyl Alcohol 70%

Purpose

First Aid Antiseptic

Uses

First aid to help prevent the risk of infection in:

• minor cuts
• scrapes
• burns

Warnings

For external use only. 

If taken internally serious gastric 

Flammable. Keep away from fire or flame, heat, spark, electrical.

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

When using this product

• do not get into eyes
• do not inhale
• do not apply over large areas of the body
• do not use longer than 1 week

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the affected area
• apply a small amount of this product on the area 1 to 3 times daily
• may be covered with a sterile bandage
• if bandaged, let dry first

Other information

• does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredient

purified water

Principal Display Panel

INGREDIENTS AND APPEARANCE

BERKLEY JENSEN  ANTISEPTIC
isopropyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 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: 76772-027-95	946 mL in 1 BOTTLE; 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(76772-027)