HAND SANITIZER SMARTIES PINEAPPLE- alcohol gel
JFL ENTERPRISES, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ANTIBACTERIAL HAND GEL Smarties Pineapple

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

Stop and Ask a doctor if

Irritation or redness develop.

HAND SANITIZER (ALCOHOL) GEL

HAND SANITIZER SMARTIES PINEAPPLE
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71246-4031
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PINEAPPLE (UNII: 2A88ZO081O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71246-4031-1	40 mL in 1 POUCH; Type 0: Not a Combination Product	02/02/2017	06/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/2017	06/30/2020

Labeler - JFL ENTERPRISES, INC (010967011)

Registrant - JFL ENTERPRISES, INC (010967011)

Name	Address	ID/FEI	Business Operations
Establishment
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(71246-4031)

Revised: 6/2020

Document Id: a7f93765-8f1d-f145-e053-2995a90ab9eb

Set id: 60b19efc-a52e-4538-b81d-c62b17d34fb6

Version: 2

Effective Time: 20200613

JFL ENTERPRISES, INC