KUNDAL FRESH WATER HAND SANITIZER- alcohol gel

Kundal Fresh Water Hand Sanitizer by

Drug Labeling and Warnings

Kundal Fresh Water Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by WHAIN COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl Alcohol (Alcohol) 62% (w/w)

INACTIVE INGREDIENT

Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Artemisia Princeps Extract

PURPOSE

Antimicrobial

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

INDICATIONS & USAGE

Store under 30°C (86°F)

WARNINGS

For external use only.

Flammable, keep away from fire or flame.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

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

DOSAGE & ADMINISTRATION

• Put enough product in your palm to thoroughly cover your hands
• Rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KUNDAL FRESH WATER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73823-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ARTEMISIA PRINCEPS WHOLE (UNII: 2849G48V9J)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73823-100-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2020

Labeler - WHAIN COSMETIC (557837595)

Registrant - WHAIN COSMETIC (557837595)

Establishment
Name	Address	ID/FEI	Business Operations
WHAIN COSMETIC		557837595	manufacture(73823-100) , label(73823-100)