FOAMING ALCOHOL INSTANT HAND SANITIZER- ethanol liquid

Foaming Alcohol Instant Hand Sanitizer by

Drug Labeling and Warnings

Foaming Alcohol Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Auto-Chlor System, LLC, Auto-Chlor System. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol 62% v/v

PURPOSE

Antiseptic handwash

INDICATIONS & USAGE

For handwashing to decrease bacteria on the skin

WARNINGS

Flammable. Keep away for fire or flame.

For External Use Only

When using this product do not use around or near eyes. If contact occurs, flush eyes with water and contact a doctor immediately. Stop use and consult a doctor when skin irritation occurs.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

Place a palmful (5 grams) of product in one hand.

Spread on both hands and rub into skin until dry (1-2 minutes).

Place a smaller amount (2.5 grams) into one hand and spread over both hands and wrists.

Rub into skin until dry.

INACTIVE INGREDIENT

Water, Siloxane Polyalkyleneoxide copolymer, glycerin, polyoxyethylene glyceryl monococoate, fragrance, citric acid

L30239 HK Foaming Alcohol IHS Label 080 20.jpg

L30239 HK Foaming Alcohol IHS Label 080 20.jpg

INGREDIENTS AND APPEARANCE

FOAMING ALCOHOL INSTANT HAND SANITIZER 
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68604-239
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	620 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68604-239-02	4 in 1 BOX	03/31/2020
1	NDC: 68604-239-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2020

Labeler - Auto-Chlor System, LLC (965194330)

Establishment
Name	Address	ID/FEI	Business Operations
Auto-Chlor System		965194330	manufacture(68604-239)