33.8OZ SANIPURE HAND SANITIZER WITH ALOE VERA AND VITAMIN E- alcohol gel 
FLPHARMACEUTICALS LLC

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.

----------

Kills 99% of Germs

SaniPure allows you to wash your hands whenever conventional soap and water is not available. Use as an aid to reduce exposure to infectious germs and to supplement daily handwashing. Helps meet U.S. Government standards by protecting against exposure to bloodborne diseases. Nontozic-For External Use Only.

Keep bottle of SaniPure in

  • Kitchen Medical Offices Nurseries
  • Automobile Bathrooms Workplace

Drug Facts
Active Ingredients

Ethyl Alcohol 75%

Purpose

Antimicrobial

Directions:

  • Wet hands thoroughly with product. Briskly rub hands together until dry.
  • Supervise children under 6 years in the use of this product. SaniPure.

Inactive Ingredients:

Aqua, Aloe Vera, Carbomer, Fragrance, Glycerin, Vitamin E, Triethanolamine.

Warning

  • Flammable, keep away from flame.
  • Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician.
  • If swallowed, contact physician.
  • For External Use Only.
  • Do not store above 110℉。

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

16.9oz SaniPure Hand Sanitizer

label

33.8OZ SANIPURE HAND SANITIZER WITH ALOE VERA AND VITAMIN E 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71724-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 15 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71724-500-98500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2020
2NDC:71724-500-991000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/11/202008/10/2020
Labeler - FLPHARMACEUTICALS LLC (080682491)
Registrant - FLPHARMACEUTICALS LLC (080682491)
Establishment
NameAddressID/FEIBusiness Operations
FLPHARMACEUTICALS LLC080682491pack(71724-500)

Revised: 11/2022
 
FLPHARMACEUTICALS LLC