OTC Medication Information: CALA HAND SANITIZER

CALA HAND SANITIZER- alcohol spray
Shin’s Trading Co., Inc. Dba Cala Products

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.

Drug Facts

Active Ingredient[s]

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use[s]

■ Hand Sanitizer to help reduce bacteria on skin ■ Recommended for repeated use

Warnings

For external use only: Hands. Flammable. Keep away from heat and flame.

Do not usein 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, Glycerin, Tetrahydroxypropyl Ethylenediamine

Questions or Comments?

1-213-745-5141

SPRAY TYPE

70% ALCOHOL

√ Non-Sticky

√ No Parabens

√ No Fragrances

MADE IN KOREA

SANITIZING & REFRESHING

CALA® PRODUCTS

LOS ANGELES, CA 90007 U.S.A.

www.calaproduct.com

Packaging

image description
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CALA HAND SANITIZER
ethyl alcohol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:74985-679
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
GLYCERIN
EDETOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:74985-679-53 500 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/20/2020
Labeler — Shin’s Trading Co., Inc. Dba Cala Products (175832021)

Revised: 08/2020 Shin’s Trading Co., Inc. Dba Cala Products

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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