Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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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.

Warnings

For external use only.

  • flammable
  • keep away from source of heat or fire

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

  • put enough product in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.

Other information

  • store at a temperature below 110°F (43°C).
  • may discolor certain fabrics or surfaces.

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 2 fl oz

image of the label 2 oz

Label copy 15 fl oz

image of the label 15 oz

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: 63148-510-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
2NDC: 63148-510-15444 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/2020
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
 
Apollo Health and Beauty Care Inc.


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