TOPCARE AMBER ANTIBACTERIAL HAND- benzalkonium chloride soap

TopCare Amber Antibacterial Hand by

Drug Labeling and Warnings

TopCare Amber Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Abaco Partners LLC DBA Surefil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

for hand washing, reduces germs on skin

Warnings

For external use only–hands only

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develops.

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

Directions

• Wash hands and rinse.

Other information

store at 20°C - 25°C (68°F - 77°F)

Inactive Ingredients

Purified Water, Cetrimonium Chloride, Glycerin, Lauramidopropylamine Oxide, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Fragrance, Citric Acid, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red #4, FD&C Yellow #5.

QUESTIONS?

1-888-423-0139

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DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 221 mL Bottle Label

TopCare®

TRICLOSAN FREE

ANTIBACTERIAL

hand
soap

AMBER

7.5 FL OZ
(221 mL)

INGREDIENTS AND APPEARANCE

TOPCARE AMBER ANTIBACTERIAL HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20890-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	13 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetrimonium Chloride (UNII: UC9PE95IBP)
Glycerin (UNII: PDC6A3C0OX)
Lauramidopropylamine Oxide (UNII: I6KX160QTV)
Coco Monoethanolamide (UNII: C80684146D)
Sodium Chloride (UNII: 451W47IQ8X)
PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Sodium (UNII: MP1J8420LU)
MethylChloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
FD&C Red No. 4 (UNII: X3W0AM1JLX)
FD&C Yellow No. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20890-0050-1	221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/15/2014
2	NDC: 20890-0050-2	1180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2014	07/08/2019
3	NDC: 20890-0050-3	1650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/15/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	12/15/2014

Labeler - Abaco Partners LLC DBA Surefil (964809417)

Establishment
Name	Address	ID/FEI	Business Operations
Abaco Partners LLC DBA Surefil		964809417	MANUFACTURE(20890-0050)