Label: CALA ADVANCED HAND SANITIZING TISSUES- alcohol swab

  • 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 September 16, 2020

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  • Drug Facts

  • Active Ingredient[s]

    Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use[s]

    ■ to reduce germs 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 or near the eyes. In case of contact, 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 ■ Wet hands thoroughly with product and allow dry. ■ Reseal tissues after each use to avoid product from drying. ■ Supervise children under 6 years of age when using this product.

  • 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, Hydroxyacetophenone, Cetylpyridinium Chloride, Citric Acid Monohydrate, Butylene Glycol, Aloe Ferox Leaf Extract

  • Questions or Comments?

    1-231-745-5141

  • SPL UNCLASSIFIED SECTION

    SANITIZING & REFRESHING

    CLEAN HANDS

    WITH ALOE VERA EXTRACT

    Pre-moistened Santizing Tissues

    5.9 x 7.9 in (15 x 20 cm)

    MADE IN KOREA

    Cleansing & Refreshing

    ADVANCED HAND SANITIZING TISSUES

    CAUTIONS: FOR EXTERNAL USE ONLY. If any product gets into eyes it may cause irritation, rinse eyes thoroughly with warm water. KEEP OUT OF REACH OF CHILDREN.

    CALA® PRODUCTS

    LOS ANGELES, CA 90007 U.S.A.

    www.calaproduct.com

    MADE IN SOUTH KOREA

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CALA ADVANCED HAND SANITIZING TISSUES 
    alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74985-678
    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)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE FEROX LEAF (UNII: 0D145J8EME)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74985-678-5530 in 1 POUCH09/11/2020
    14.19 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:74985-678-5660 in 1 POUCH09/11/2020
    24.65 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2020
    Labeler - Shin's Trading Co., Inc. Dba Cala Products (175832021)
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