Label: CALA HAND SANITIZER- ethyl alcohol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated August 20, 2020

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  • 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 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, Glycerin, Tetrahydroxypropyl Ethylenediamine

  • Questions or Comments?

    1-213-745-5141

  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    CALA HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74985-679
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETOL (UNII: Q4R969U9FR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74985-679-53500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - Shin's Trading Co., Inc. Dba Cala Products (175832021)
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