HAND SANITIZER- ethyl alcohol gel

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient
Alcohol 67%

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

Uses

for handwashing to decrease bacteria on the skin.

WARNINGS

Warnings

For external use only. Flammable, keep away from fire or flame.

Do not use in the eyes.In case of contact, flush eyes with water.

STOP USE

Stop use and ask a doctor if

• irritation and redness develop.
• condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

wet hand thoroughly with product and allow to dry without wiping

STORAGE AND HANDLING

Other information

store at a temperature below 110 F(43 C)

INACTIVE INGREDIENT

Inactive ingredients

water(aqua), aloe vera leaf juice, glycerin, propylene glycol, fragrance(parfum), acrylates/C30-10 alkyl acrylate crosspolymer, aminomethyl propanol, mannitol, microcrystalline cellulose, sucrose, corn(zea mays) starch, hydroxpropyl methyl cellulose, tocopheryl acetate, denatonium benzonate, maltodextrin, alpha-isomethyl ionone, amyl cinnamal, amylcinnamyl alcohol, benzyl salicylate, hexyl cinnamal, Iron Oxides, FD&C Red No.4, FD&C Yellow No.5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72866-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	67 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
.ALPHA.-IONONE (UNII: I9V075M61R)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MANNITOL (UNII: 3OWL53L36A)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE (UNII: C151H8M554)
STARCH, CORN (UNII: O8232NY3SJ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
.ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72866-103-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/18/2019

Labeler - Merci Handy Corporation (116958007)