CAREONE- benzalkonium chloride soap 
Retail Business Services, LLC

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 (Cl 19140), Yellow 6 (Cl 15985).

PDP03

PDP03

CAREONE 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-003
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
GLYCERIN (UNII: PDC6A3C0OX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
BASIC YELLOW 5 (UNII: 07BP340B4T)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRUS NOBILIS (UNII: 8MFF77J91V)  
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
DIRECT YELLOW 6 (UNII: 9CU9YEE7RC)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-003-03333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/26/2021
Labeler - Retail Business Services, LLC (967989935)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Spa Dent Inc203478896manufacture(72476-003)

Revised: 9/2021
Document Id: cb072cfb-fb11-735e-e053-2a95a90a2867
Set id: cb062055-51a5-30ab-e053-2995a90a534a
Version: 1
Effective Time: 20210902
 
Retail Business Services, LLC