TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN- benzalkonium chloride liquid

TopCare Antibacterial Hand Fresh and Clean by

Drug Labeling and Warnings

TopCare Antibacterial Hand Fresh and Clean by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, 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. In case of contac, flush with water.

Stop using this product 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

• Use only to refill a Liquid Hand Soap pump bottle.
• From pump bottle, apply onto wet hands.
• Lather and rinse thoroughly.

Other information

store at room temperature.

Inactive ingredients

Water (Aqua), Lauramidopropylamine Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200).

Questions or comments?

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Label Copy

INGREDIENTS AND APPEARANCE

TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-534
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)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
GLYCERIN (UNII: PDC6A3C0OX)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM SULFATE (UNII: 0YPR65R21J)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-534-56	1656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/20/2019

Labeler - Topco Associates LLC (006935977)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(36800-534)