BERKLEY JENSEN- benzalkonium chloride soap

berkley jensen by

Drug Labeling and Warnings

berkley jensen by is a Otc medication manufactured, distributed, or labeled by Apollo Health and Beauty Care, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient.

Benzalkonium Chloride (0.13%)

Purpose

Antibacterial

Uses

Helps eliminate bacteria on hands.

Warnings

For external use only

When using this product

Avoid contact with eyes. If this occurs, rinse thoroughly with water.

Stop use and ask a doctor if

irritation or redness develops and lasts

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Directions

• Apply a small amount onto wet hands
• Work into a lather and rinse

Other Information

Store at room temperature

Inactive Ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamide Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG – 120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Citrus Nobillis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract. Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Blue 1 (Cl 42090),

Principal Display Panel

INGREDIENTS AND APPEARANCE

BERKLEY JENSEN 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM SULFATE (UNII: 0YPR65R21J)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
WATER (UNII: 059QF0KO0R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
BASIC YELLOW 5 (UNII: 07BP340B4T)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRUS NOBILIS (UNII: 8MFF77J91V)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-400-11	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/15/2022

Labeler - Apollo Health and Beauty Care (201901209)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(63148-400)