HANDSOAP- benzalkonium chloride soap

Handsoap by

Drug Labeling and Warnings

Handsoap by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Apollo Health and Beauty Care Inc, Spa Dent Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride

PURPOSE

Handwashing

WARNINGS

For External Use only

WHEN USING

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

STOP USE

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

INDICATIONS & USAGE

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.

STORAGE AND HANDLING

Store at room temperature

INACTIVE INGREDIENT

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).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HANDSOAP 
benzalkonium chloride soap

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Topco Associates LLC (006935977)

Registrant - Apollo Health and Beauty Care Inc (201901209)

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