BERKLEY JENSEN- witch hazel 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Witch Hazel--------86%

Purpose

Astringent

Indications

For relief of minor skin Irritations due to

minor cuts

minor scraps

insect bites

Warnings

For external use only

avoid contact with eyes

If contact occurs rinse thoroughly with water.

When using this product stop using and contact a doctor if

condition persists or gets worse

symptoms do not improve within 7 days

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

In case of eye contact flush eyes with running water for 15 minutes.

Directions

Apply liberally to the afflicted area as often as necessary

Inactive ingredients

Alcohol 14%

New label

INGREDIENTS AND APPEARANCE

BERKLEY JENSEN 
witch hazel liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76772-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	855 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76772-029-95	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 final	part347	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(76772-029)