CALA ADVANCED HAND SANITIZER- alcohol gel

CALA ADVANCED HAND SANITIZER by

Drug Labeling and Warnings

CALA ADVANCED HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by David Cosmetic Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient [s]

Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

▪ to reduce bacteria on the skin that could cause disease ▪ recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from heat or flame.

Do not use ▪ in 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.

DOSAGE & ADMINISTRATION

​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.

STORAGE AND HANDLING

Other Information ▪ Store between 15°C to 30°C(59°F to 86°F) ▪ Avoid freezing and excessive heat above 40°C(104°F)

INACTIVE INGREDIENT

Inactive ingredients Water, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Extract, Butylene Glycol, 1,2-Hexanediol, Menthol

Questions or Comments?

1-213-745-5141

SPL UNCLASSIFIED SECTION

Gel Hydratant Aloe Vera

√ Deep Moisturizing

√ Non-Sticky

MOISTURISING & REFRESHING

KILLS HARMFUL GERM ON THE SKIN!

MADE IN KOREA

CALA® PRODUCTS

LOS ANGELES, CA 90007, U.S.A.

www.calaproduct.com

Packaging

INGREDIENTS AND APPEARANCE

CALA ADVANCED HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58241-0009
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58241-0009-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/02/2020

Labeler - David Cosmetic Co Ltd (695697845)

Registrant - David Cosmetic Co Ltd (695697845)

Establishment
Name	Address	ID/FEI	Business Operations
David Cosmetic Co Ltd		695697845	manufacture(58241-0009)