CAREONE VANILLA BUTTERCREAM 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

Warnings

For external use only

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop using this product 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 a temperature below 110°F (43°C)

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Red 33 (CI 17200), Yellow 5 (CI 19140).

Label Copy

Image of the label 8oz

Image of the label 2 oz

CAREONE VANILLA BUTTERCREAM HAND SANITIZER 
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-058
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)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-058-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2017
2NDC:41520-058-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/25/2017
Labeler - American Sales Company (809183973)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(41520-058)

Revised: 9/2017
Document Id: 64b5b6e4-4935-4d8a-8581-dc1240ba16a9
Set id: 4982a1bd-a4f4-4db9-9798-9b1e9ae34348
Version: 1
Effective Time: 20170926
 
American Sales Company