OTC Medication Information: CALA ADVANCED HAND SANITIZER

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.

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
(click image for full-size original)

CALA ADVANCED HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58241-0009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
TROLAMINE
ALOE VERA LEAF
BUTYLENE GLYCOL
1,2-HEXANEDIOL
MENTHOL, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58241-0009-1 500 mL in 1 BOTTLE, PUMP None
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 Operations
David Cosmetic Co Ltd 695697845 manufacture (58241-0009)

Revised: 10/2021 David Cosmetic Co Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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