Label: SPATHERAPY VANILLA COCONUT- hand sanitizer gel

  • NDC Code(s): 73025-030-01
  • Packager: Shalom International Corp
  • 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 May 26, 2019

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  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children

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  • ACTIVE INGREDIENT

    Alcohol Denatured 60% w/w

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  • INDICATIONS & USAGE

    Use: To decrease bacteria on the skin and clean hands. Recommended for repeated use.

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  • PURPOSE

    Purpose: Antibacterial

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  • DOSAGE & ADMINISTRATION

    Directions: Apply to hands until thoroughly wet. Rub vigorously until dry.

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  • Spatheraphy Vanilla Coconut
  • INGREDIENTS AND APPEARANCE
    SPATHERAPY VANILLA COCONUT 
    hand sanitizer gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:73025-030
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 1 mL  in 0.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:73025-030-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/31/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 05/31/2019
    Labeler - Shalom International Corp (103291209)
    Registrant - Regulatory Matters Consulting (080711165)
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