HANDSOAP- benzalkonium chloride soap
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topcare Antibacterial Hand Soap.

Benzalkonium Chloride

Handwashing

For External Use only

Avoid contact with eyes. In case of contact, flush with water

Stop using this product and ask a doctor if irritation or redness develops and lasts.

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.

Dosage Section

Topical use only. Use when required.

Store at room temperature

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).

56 oz

HANDSOAP
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-535
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM SULFATE (UNII: 0YPR65R21J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:36800-535-56	1650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/12/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/12/2022

Labeler - Topco Associates LLC (006935977)

Registrant - Apollo Health and Beauty Care Inc (201901209)

Name	Address	ID/FEI	Business Operations
Establishment
Spa Dent Inc		203478896	manufacture(36800-535)