CAREONE CITRUS FRESH ANTIBACTERIAL HAND- benzalkonium chloride soap 
American Sales Company

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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

helps eliminate bacteria on hands.

Warnings

For external use only.

When using this product

  • avoid contact with eyes. In case of contact, rinse thoroughly with water.

Stop use 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. 

Directions 

Other information

store at room temperature. 

Inactive ingredients

Water (Aqua), Cetrimonium Chloride, Lauramidopropylamine Oxide, Glycerin, Sodium Chloride, Cocamide MEA, PEG-120 Methyl Glucose Dioleate, Citrus Nobilis (Mandarin Orange) Peel Extract, Camellia Sinensis Leaf Extract, Zingiber Officinale (Ginger) Root Extract, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Yellow 6 (CI 15985).

Label copy

image of the label

CAREONE CITRUS FRESH ANTIBACTERIAL HAND 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
TANGERINE PEEL (UNII: JU3D414057)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GINGER (UNII: C5529G5JPQ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-303-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/18/2019
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-303)

Revised: 7/2019
Document Id: 7b761ae2-cb2f-460d-b38f-34afd7206816
Set id: 89bdf6e8-9d73-4f39-8a5d-4d6e8f4081c4
Version: 1
Effective Time: 20190719
 
American Sales Company