CAREONE ANTIBACTERIAL SANITIZER LIMONCELLO- ethyl alcohol liquid 
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

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse 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

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green (CI 77289), Blue 1 (CI 42090), Yellow 5 (CI 19140).

Label Copy

Image of the label

CAREONE  ANTIBACTERIAL SANITIZER LIMONCELLO
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-411-0359 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/25/2017
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-411)

Revised: 4/2017
Document Id: 37091932-e5e7-4412-b7dc-aef5cde6f03d
Set id: b53e8d23-22cc-4e3b-81ad-77777821a1ee
Version: 1
Effective Time: 20170426
 
American Sales Company