CAREONE ALOE AND VITAMIN E HAND SANITIZER- 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 help reduce bacteria on the skin.

Warnings

For external use only

When using this product

avoid contact with eyes. If contact occurs, 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

Inactive ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Questions or comments?

1-877-846-9949

Label Copy

Image of the Label 2oz

Image of the Label 8oz

CAREONE ALOE AND VITAMIN E HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-006
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 MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-006-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/18/2017
2NDC:41520-006-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/18/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/18/2017
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-006)

Revised: 10/2017
Document Id: a79b5859-75cb-4b98-b076-ada78dbf30ef
Set id: fd4c731d-6ae5-416c-8d6b-8da70a3bdcd9
Version: 1
Effective Time: 20171019
 
American Sales Company