REFRESHING GEL HAND SANITIZER- alcohol gel

Refreshing Gel Hand Sanitizer by

Drug Labeling and Warnings

Refreshing Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Whole Foods Market, KDC/ONE Cosmetic Laboratories of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 62% w/w

Purpose

Antiseptic

Use

to help reduce bacteria on the skin

Warnings

• For external use only.
• Flammable. Keep away from fire or flame.
• When using this product, avoid contact with eyes. If eye contact occurs, rinse with water.
• Stop use and ask a doctor if skin irritation or redness develops.

Keep Out of Reach of Children

In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times daily.

Other information

do not store above 104°F (40°C).

Inactive Ingredients

water, carbomer, glycerin, caprylic/capric triglyceride, aminomethyl propanol

DISTRIBUTED BY:

WHOLE FOODS MARKET

AUSTIN, TX 78703

©2020 WHOLE FOODS MARKET IP, LP

www.wholefoodsmarket.com

Questions, Comments?

• customer.questions@wholefoods.com
• 1-844-936-8255

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

REFRESHING GEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42681-0021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	69 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42681-0021-1	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/08/2020

Labeler - Whole Foods Market (196175616)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE Cosmetic Laboratories of America Inc.		117449842	MANUFACTURE(42681-0021)