AWAKEN BY QUALITY CHOICE HAND SANITIZER VANILLA CRM AND APPLE BLOSSOM- ethyl alcohol liquid 
Chain Drug Marketing Association 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

helps eliminate bacteria on hands.

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 hand 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), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Vanilla Planifolia Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Retinyl Palmitate, Hydroxypropyl Methylcellulose, Panthenol, Iron Oxides (CI 77491), Titanium Dioxide (CI 77891), Red 33 (CI 17200).

Questions or comments?

1-284-449-9300

Label Copy

Image of the label

AWAKEN BY QUALITY CHOICE HAND SANITIZER  VANILLA CRM AND APPLE BLOSSOM
ethyl alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-476
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)  
VANILLA (UNII: Q74T35078H)  
APPLE (UNII: B423VGH5S9)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MANNITOL (UNII: 3OWL53L36A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
PANTHENOL (UNII: WV9CM0O67Z)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-476-08259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/201607/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/18/201607/01/2023
Labeler - Chain Drug Marketing Association Inc (011920774)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture(63868-476)

Revised: 7/2023
 
Chain Drug Marketing Association Inc