HAND SANITIZER- ethyl alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by FIFTEEN DEGREES co.,ltd, FARMER'S GRAIN KOREA LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol 70%

WARNINGS

Warnings
Flammable. Keep away from fire or flame

For external use only

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 or contact a Poison Control

Center right away.

DOSAGE & ADMINISTRATION

Directions

● Put enough product in your palm to cover hands and rub hands together briskly until dry

● Children under 6 years of age should be supervised when using this product

INACTIVE INGREDIENT

Inactive ingredients

Water, Glycerin, Propylen Glycol, Carbomer,
Aminomethyl propanol, Citrus Limon(Lemon) Peel Oil,
Tocopheryl Acetate

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.

INDICATIONS & USAGE

Use: Hand sanitizer to help reduce bacteria on the skin

PURPOSE

purpose topical antimicrobial

PRINCIPAL DISPLAY PANEL

NDC: 74753-783-05

ATEM

Hand cleaner

sanitizer

ethanol 70%

500 mL (16.9 fl oz)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74753-783
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
LEMON OIL (UNII: I9GRO824LL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74753-783-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2020
2	NDC: 74753-783-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2020
3	NDC: 74753-783-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/11/2020

Labeler - FIFTEEN DEGREES co.,ltd (694982014)

Registrant - FARMER'S GRAIN KOREA LTD (694439983)

Establishment
Name	Address	ID/FEI	Business Operations
FARMER'S GRAIN KOREA LTD		694439983	manufacture(74753-783)