HAND SANITIZER BIRTHDAY CAKE- 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 Dippin Dots Birthday Cake

Active ingredient

Alcohol 62%

Purpose

Antiseptic Hand Sanitizer

Use

Decrease bacteria on hands

Warnings

External Use Only. DO NOT EAT.

Keep out of reach of children

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

Flammable: Keep away from flame or high heat

Directions

Rub hands thoroughly with product and allow to dry.

Inactive Ingredient

Carbomer, Glycerin, Jojoba Particles, Chocolate & Cream Extract, Pigment Red GB106-30-40, Blue 318C Propylene Glycol, Triethanolamine, Water.

Stop and Ask a doctor if

Irritation or redness develop.

HAND SANITIZER (ALCOHOL) GEL

Label Image
HAND SANITIZER BIRTHDAY CAKE 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71246-4013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)  
PIGMENT RED 1 (UNII: D54Q24K2EI)  
JOJOBA ACID (UNII: MO7HV04S9Y)  
PIGMENT BLUE 1 (UNII: 4SBE571RQF)  
CHOCOLATE BROWN HT FREE ACID (UNII: RH77QMZ6Y1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71246-4013-140 mL in 1 POUCH; Type 0: Not a Combination Product02/02/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A02/01/2017
Labeler - JFL ENTERPRISES, INC (010967011)
Establishment
NameAddressID/FEIBusiness Operations
NingBo Huize Commodity Co.,Ltd.544434795manufacture(71246-4013)

Revised: 1/2018
Document Id: 5954e946-3523-4e75-aff1-f3c11f4f2aea
Set id: c5a4b2eb-a8ba-4dd4-a3a8-5af9578c8d5f
Version: 1
Effective Time: 20180101
 
JFL ENTERPRISES, INC