ANTIBACTERIAL HAND GEL Smarties Pineapple

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
JFL ENTERPRISES, INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Alcohol 62%.................................................Antiseptic Antiseptic Hand Sanitizer Decrease bacteria on hands
Authorization status:
OTC monograph not final
Authorization number:
71246-4031-1

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

Purpos e

Antiseptic Hand Sanitizer

Us e

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 T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:71246 -40 31

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

6 2 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

CARBO MER HO MO PO LYMER TYPE B ( ALLYL SUCRO SE CRO SSLINKED) (UNII: Z135WT9 20 8 )

TRIETHANO LAMINE 2 -CYCLO HEXYL-4 ,6 -DINITRO PHENO LATE (UNII: N2TK31JIAH)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

PINEAPPLE (UNII: 2A8 8 ZO0 8 1O)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:71246 -40 31-1

40 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 2/20 17

0 6 /30 /20 20

JFL ENTERPRISES, INC

1

NDC:71246 -40 31-1

40 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 2/20 17

0 6 /30 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 2/0 1/20 17

0 6 /30 /20 20

Labeler -

JFL ENT ERPRISES, INC (010967011)

Registrant -

JFL ENT ERPRISES, INC (010967011)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bath Co ncept Co smetics (Do ngguan) Co ., Ltd

529 6 239 33

ma nufa c ture (71246 -40 31)

Revised: 6/2020

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