Drug Facts

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

To kill bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not us

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

When using this product

keep out of eyes. In case of contact with eyes, rinse thoroughly with water.

Stop us and ask a doctor

if irritation or rash occurs or condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222

Directions

Dispense a dime-sized amount onto your hands or sufficient amount to cover area, and massage thoroughly until the product is absorbed. Supervise children under 6 years of age when using this product. Not recommended for infants.

Inactive Ingredients

Water (Aqua), Glycerin, Isopropyl Alcohol, Butylene Glycol, Lavandula Angustifolia (Lavender) Oil, Carbomer, Aminomethyl Propanol, Isopropyl Myristate, Linalool, Tocopheryl Acetate, Shea Butter Ethyl Esters, Sodium Ascorbyl Phosphate, Rosa Damascena Flower Extract, Geraniol, Limonene

Package Labeling:

Label

CLEARED FOR TAKE OFF HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83617-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83617-001-00	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/11/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	505G(a)(3)	11/11/2022

Labeler - Careeon LLC (119058531)

Cleared For Take Off Hand Sanitizer