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NDC 36800-0534-56 TopCare Antibacterial Hand Fresh and Clean 1.3 mg/mL Details

TopCare Antibacterial Hand Fresh and Clean 1.3 mg/mL

TopCare Antibacterial Hand Fresh and Clean is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	36800-0534
Product ID	36800-534_e8745b0f-0639-14de-e053-2a95a90a038f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TopCare Antibacterial Hand Fresh and Clean
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Topco Associates LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2023-12-31

Package

Package Images

NDC 36800-0534-56 (36800053456)

Pricing Information	N/A
NDC Package Code	36800-534-56
Billing NDC	36800053456
Package	1656 mL in 1 BOTTLE, PLASTIC (36800-534-56)
Marketing Start Date	2019-06-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 182a9b33-1b40-4a8b-8a89-210ce1483205 Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Topco Associates LLC (006935977)

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

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

Revised: 9/2022

Document Id: e8745b0f-0639-14de-e053-2a95a90a038f

Set id: 182a9b33-1b40-4a8b-8a89-210ce1483205

Version: 3

Effective Time: 20220912