HANDSOAP- benzalkonium chloride soap

Handsoap by

Drug Labeling and Warnings

Handsoap by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Antibacterial

ACTIVE INGREDIENT

Benzalkonium Chloride.

WARNINGS

For External Use only

In case of accidental ingestion, seek medical attention or contact a poison control centre immediately

ask a doctor ifIrritation or redness develops and lasts

DOSAGE & ADMINISTRATION

Apply onto dry hands. Work into a lather, rinse and dry throughly.

STORAGE AND HANDLING

Store at room temperature

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

Helps eliminate bacteria on skin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HANDSOAP 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-703
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
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM SULFATE (UNII: 0YPR65R21J)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDE MIPA (UNII: 21X4Y0VTB1)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
EDETATE SODIUM (UNII: MP1J8420LU)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-703-56	1660 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2024
2	NDC: 51316-703-11	333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2024
3	NDC: 51316-703-50	1470 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	12/01/2021

Labeler - CVS Pharmacy (062312574)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(51316-703)