BERKLEY JENSEN ANTIBACTERIAL HAND- benzalkonium chloride liquid

BERKLEY JENSEN by

Drug Labeling and Warnings

BERKLEY JENSEN by is a Otc medication manufactured, distributed, or labeled by BJWC, APOLLO HEALTH AND BEAUTY CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13%

PURPOSES

ANTIBACTERIAL

USES

HELPS ELIMINATE BACTERIA ON HANDS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IN CASE OF CONTACT, RINSE 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, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

APPLY ONTO WET HANDS. LATHER AND RINSE THOROUGHLY

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), COCAMIDOPROPYL BETAINE, GLYCERIN, DECYL GLUCOSIDE, HYDROXYETHYLCELLULOSE, ALOE BARBADENSIS LEAF JUICE, FRAGRANCE (PARFUM), POLOXAMER 124, POLYQUATERNIUM-7, TETRASODIUM EDTA, CITRIC ACID, SODIUM CITRATE, CAMELLIA SINENSIS LEAF EXTRACT, SACCHAROMYCES FERMENT, TOCOPHERYL ACETATE, RETINYL PALMITATE, ASCORBYL PALMITATE, NIACINAMIDE, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, BLUE 1 (CI 42090), RED 33 (CI 17200)

QUESTIONS OR COMMENTS?

1-800-934-1204

LABEL COPY

INGREDIENTS AND APPEARANCE

BERKLEY JENSEN  ANTIBACTERIAL HAND
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68391-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLOXAMER 124 (UNII: 1S66E28KXA)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
NIACINAMIDE (UNII: 25X51I8RD4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68391-150-64	1890 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/09/2014

Labeler - BJWC (159082692)

Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
APOLLO HEALTH AND BEAUTY CARE		201901209	manufacture(68391-150)