HAND SANITIZER- alcohol gel 
HPPE, 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.

----------

ACTIVE INGREDIENT

Alcohol 70% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

USE

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only. Flammable. Keep away from heat or flame.

DO NOT USE

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

hydroxyethylcellulose, isopropyl myristate, propylene glycol, water

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

237 mL NDC: 58039-119-03

237 mL Label355 mL NDC: 58039-119-04

355 mL Label473 mL NDC: 58039-119-05

473 mL Label

3.8 L NDC: 58039-119-06

Front Label 3.8 L

Back Label 3.8 L

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58039-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58039-119-03237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
2NDC:58039-119-04355 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
3NDC:58039-119-05473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/16/2020
4NDC:58039-119-063800 mL in 1 JUG; Type 0: Not a Combination Product06/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/16/2020
Labeler - HPPE, LLC (078769356)
Establishment
NameAddressID/FEIBusiness Operations
HPPE, LLC078769356manufacture(58039-119)

Revised: 6/2020
Document Id: a84a4879-321b-7d2d-e053-2995a90abca7
Set id: a84a4879-321a-7d2d-e053-2995a90abca7
Version: 1
Effective Time: 20200617
 
HPPE, LLC