KEEN ESSENTIALS HAND SANITIZER- alcohol gel

KEEN ESSENTIALS HAND SANITIZER by

Drug Labeling and Warnings

KEEN ESSENTIALS HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by YESROAD COSMETICS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

alcohol

INACTIVE INGREDIENT

Water
Glycerin

Carbomer

Helianthus Annuus Hybrid (Sunflower) oil
Chamomilla Recutita (Matricaria) Extract
Butylene Glycol

Aloe Barbadensis Leaf Extract

Butylene Glycol

1,2-Hexanediol

Aminomethyl Propanol

PURPOSE

for hand-washing to decrease bacteria on the skin, only when water is not available

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

wet hands thoroughly with product and allow to dry without wiping

WARNINGS

Flammable, keep away from fire and flames
Fot external use only.

DOSAGE & ADMINISTRATION

For external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KEEN ESSENTIALS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78924-0001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78924-0001-1	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2020
2	NDC: 78924-0001-2	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2020
3	NDC: 78924-0001-3	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/13/2020

Labeler - YESROAD COSMETICS CO.,LTD (557826071)

Registrant - YESROAD COSMETICS CO.,LTD (557826071)

Establishment
Name	Address	ID/FEI	Business Operations
YESROAD COSMETICS CO.,LTD		557826071	manufacture(78924-0001)