Waxman Hand Sanitizer 80765-001

Waxman Kleen Freak Hand Sanitizer by

Drug Labeling and Warnings

Waxman Kleen Freak Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by WAXMAN CONSUMER PRODUCTS GROUP INC., Southern Distilling Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WAXMAN KLEEN FREAK HAND SANITIZER- alcohol gel 
WAXMAN CONSUMER PRODUCTS GROUP 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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Waxman Hand Sanitizer 80765-001

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

  • On children less than 2 months of age
  • On open skin wounds

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.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • Store between 15-30 C (59-86 F)
  • Avoid freezing and excessive heat above 40 C (104F)

Inactive Ingredients

Liquid Preneutralized Thicker/Emulsifier, Citric Acid, Glycerin. Water

Kills

99.9%

of Germs*

waxman

kleen

freak

hand sanitizer

Contains 70% alcohol

Tough on bacteria but gentle on skin

16 fl oz (473 mL)

container label

WAXMAN KLEEN FREAK HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80765-001
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 80765-001-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
2NDC: 80765-001-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product10/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E10/22/202012/31/2021
Labeler - WAXMAN CONSUMER PRODUCTS GROUP INC. (877456673)
Establishment
NameAddressID/FEIBusiness Operations
Southern Distilling Company, LLC046275910manufacture(80765-001)

Revised: 7/2022
Document Id: e4f49212-2829-d673-e053-2a95a90a1086
Set id: b2439a39-6409-7b6d-e053-2995a90a2863
Version: 3
Effective Time: 20220729