CALA ADVANCED HAND SANITIZER- alcohol gel 
David Cosmetic Co Ltd

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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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.

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.

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

Questions or Comments?

1-213-745-5141

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

Cala1

CALA ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58241-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58241-0009-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/02/2020
Labeler - David Cosmetic Co Ltd (695697845)
Registrant - David Cosmetic Co Ltd (695697845)
Establishment
NameAddressID/FEIBusiness Operations
David Cosmetic Co Ltd695697845manufacture(58241-0009)

Revised: 10/2021
Document Id: ce391429-cedb-6616-e053-2995a90a1b17
Set id: a96e7100-4ba9-1e45-e053-2a95a90ab0c9
Version: 2
Effective Time: 20211013
 
David Cosmetic Co Ltd