HAND SANITIZER- antibacterial hand sanitizer 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.

----------

Pineapple - Antibacterial Hand Sanitizer

Active Ingredient - Ethyl Alcohol 62%.....Antiseptic

Purpose - Antiseptic

Use

To decrease bacteria on hands 

Warnings

For external use only

Flammable, keep away from fire or flame

Keep out of reach of children

If accidently swallowed, get medical help or contact a Poison Control Center right away

WHEN USING SECTION

Keep out of eyes,In case of contact flush eyes with water.

Avoid contact with broken skin.

Discontinue use if irritation or redness develop. 

Directions

Inactive Ingredients

Water, Glycerin, Carbomer, Fragrance, Propylene Glycol, Carbomer Aminomethyl Propanol,Yellow NO 5

sani8

HAND SANITIZER 
antibacterial hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71246-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL620 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71246-0008-659.14 mL in 1 BOTTLE; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - JFL Enterprises, Inc. (010967011)

Revised: 6/2020
Document Id: a7e9b1ed-8d80-0867-e053-2995a90a6ede
Set id: 85e1dfc9-1b0d-4982-ae3e-a7fe20cd683e
Version: 2
Effective Time: 20200612
 
JFL Enterprises, Inc.