NATURAL CONCEPTS VITAMIN E HAND SANITIZER- ethyl alcohol gel 
Apollo Health and Beauty Care Inc.

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. For use when soap and water are not available.

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.

Do not use 

  • on children less than 2 months of age
  • on open skin wounds

Directions

Other information

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Questions or comments?

1-866-695-3030

Label Copy

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Label Copy - 40 fl oz

image of the label 40

Label Copy - 64 fl oz

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NATURAL CONCEPTS VITAMIN E HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-510
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER 934 (UNII: Z135WT9208)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63148-510-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
2NDC:63148-510-401182 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
3NDC:63148-510-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/13/2020
Labeler - Apollo Health and Beauty Care Inc. (201901209)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Essence, LLC825646862manufacture(63148-510)

Revised: 3/2020
Document Id: 30af951e-a431-4ec3-8230-404cb5f12601
Set id: eb89ec43-e0d6-4fd5-906e-65258e73dfb0
Version: 3
Effective Time: 20200330
 
Apollo Health and Beauty Care Inc.