HANDSOAP- benzalkonium chloride soap 
CVS Pharmacy Inc.

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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Benzalkonium Chloride

Antibacterial- Helps eliminate bacteria on hands.

For external use only

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

Stop use and ask a doctor if irritation or redness develops and lasts

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

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

Store at room temperature

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).

Helps eliminate bacteria on the skin

PDP 132oz

HANDSOAP 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-705
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51316-705-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/04/2022
2NDC:51316-705-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/04/2022
Labeler - CVS Pharmacy Inc. (062312574)
Registrant - Apollo Health and Beauty Care Inc (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(51316-705)

Revised: 8/2022
Document Id: e582bdcf-0d8c-39f1-e053-2995a90a01f2
Set id: e582bdcf-0d8b-39f1-e053-2995a90a01f2
Version: 1
Effective Time: 20220805
 
CVS Pharmacy Inc.