HAND SANITIZER SMARTIES ORANGE CREAM- alcohol gel

Hand Sanitizer Smarties Orange Cream by

Drug Labeling and Warnings

Hand Sanitizer Smarties Orange Cream by is a Otc medication manufactured, distributed, or labeled by JFL ENTERPRISES, INC, Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient Purpose

Alcohol 62%.................................................Antiseptic

Purpose

Antiseptic Hand Sanitizer

Use

Decrease bacteria on hands

Warnings

External Use Only.

Flammable: Keep away from flame or high heat

Keep out of reach of children

if swallowed get medical help or contact a Poison Control Center right away.

When using this product

keep out of eyes. In case of contact flush eyes with water. Avoid contact with broken skin.

Directions

Rub hands thoroughly with product and allow to dry.

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Fragrance, Yellow NO. 5, Red NO. 4

Stop and Ask a doctor if

Irritation or redness develop.

HAND SANITIZER (ALCOHOL) GEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER SMARTIES ORANGE CREAM 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71246-4030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ORANGE OIL (UNII: AKN3KSD11B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71246-4030-1	40 mL in 1 POUCH; Type 0: Not a Combination Product	02/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	02/01/2017

Labeler - JFL ENTERPRISES, INC (010967011)

Establishment
Name	Address	ID/FEI	Business Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(71246-4030)