HANDSOAP- benzalkonium chloride soap

Handsoap by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride

PURPOSE

Antibacterial- Helps eliminate bacteria on hands.

WARNINGS

For external use only

Avoid contact with eyes, If this occurs, rinse throughly with water.

Stop use and ask a doctor ifirritation or redness develops and lasts

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

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), Cocamidopropyl Betaine, Polysorbate 20, Fragrance (Parfum), Glycerin, Decyl Glucoside, Hydroxyethylcellulose, Aloe Barbadensis, Camellia Sinensis Leaf Extract, Propylene Glycol, Polyquaternium-7, Tetrasodium EDTA, Sodium Citrate, Citric Acid, Benzophenone -4, Methylcholoroisothiazolinone, Methylisothiazolinone, Blue 1 (Cl 42090), Ext. Violet 2 (Cl 60730).

INDICATIONS & USAGE

Helps eliminate bacteria on the skin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HANDSOAP 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-705
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
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
EDETATE SODIUM (UNII: MP1J8420LU)
DIRECT BLUE 1 (UNII: 8NN34MAQ6H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-705-07	222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2022
2	NDC: 51316-705-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	08/04/2022

Labeler - CVS Pharmacy Inc. (062312574)

Registrant - Apollo Health and Beauty Care Inc (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(51316-705)