Label: CALA ADVANCED HAND SANITIZER- alcohol gel

  • 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 October 13, 2021

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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.

  • 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

    Cala1

  • INGREDIENTS AND APPEARANCE
    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)
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