HAND SANITIZER- ethyl alcohol gel 
Kem Krest LLC

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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Active Ingredient[s]

Ethyl Alcohol 62%

Purpose

Antiseptic

Use[s]

For hand washing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame. For external use only. Avoid contact with broken skin.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed get medical help.

Directions

Not recommended for infants. Wet hands thoroughly with product and allow to dry without wiping. Children under 6 years of age should be supervised when using this product.

Other information

Do not store above 110 F (43°C). May discolor some fabrics.

Inactive ingredients

Water(Aqua), Glycerin, propylene Glycol, Acrylates/C10-30Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, fragrance(Parfum), Denatonium Benzoate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Maltodextrin.

image of bottle label

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74242-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74242-110-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/20/2020
Labeler - Kem Krest LLC (933954179)

Revised: 7/2020
Document Id: aae8ad23-ee08-23e2-e053-2995a90afcd4
Set id: aae8a9bf-9305-38a7-e053-2995a90a495b
Version: 1
Effective Time: 20200720
 
Kem Krest LLC