NORWEX (as PLD) - HAND SANITIZER GEL - 70% ETHYL ALCOHOL (80971-101) - DELIST

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Norwex Usa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER HOSPITAL AND INDUSTRIAL STRENGTH- ethyl alcohol gel 
Norwex Usa, 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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NORWEX (as PLD) - HAND SANITIZER GEL - 70% ETHYL ALCOHOL (80971-101) - DELIST

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

• HAND SANITIZER TO HELP REDUCE BACTERIA THAT COULD CAUSE DISEASE
• RECOMMENDED FOR REPEATED USE.

WARNINGS

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

• AVOID CONTACT WITH EYES AND BROKEN SKIN. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF

• REDNESS OR IRRITATION DEVELOP
• CONDITION PERSISTS FOR MORE THAN 72 HOURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT THE POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

• PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES.
• RUB HANDS TOGETHER UNTIL DRY.
• FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.
• NOT RECOMMENDED FOR INFANTS.

INACTIVE INGREDIENTS

WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, ALOE BARBADENSIS (ACOE VERA) LEAF.

QUESTIONS?

• FOR QUESTIONS, COMMENTS AND REPORT SERIOUS SIDE EFFECTS, CALL 1-866-450-7499 (M - F, 8:00 A.M. - 5:00 P.M. CST)

HAND SANITIZER  HOSPITAL AND INDUSTRIAL STRENGTH
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80971-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80971-101-06	177.4 mL in 1 TUBE; Type 0: Not a Combination Product	10/29/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/29/2020	12/31/2021

Labeler - Norwex Usa, Inc. (016707931)

Revised: 4/2023

Document Id: f8d8deaf-34e6-f5eb-e053-6394a90a75b6

34390-5

Set id: 9cffda7b-908b-48dd-bfdf-68cf0eb637ca

Version: 2

Effective Time: 20230408