Label: HAND SANITIZER- denatured dt ethyl alcohol liquid

  • 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 July 5, 2020

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  • Use(s)

    To help reduce bacteria on the skin. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • around eyes
    • in ears and mouth

    When using this product

    keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if

    irritation or rash occurs.

    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 15-30C (59-86F)
    • Avoid freezing and exessive heat above 40C (104F)
  • Inactive ingredients

    Aloe Barbadenisis (leaf) Extract, Fragrance, Glycerin, Purified Water

  • Manufactured by:

    Sun Wave Wellness, LLC

    1419 Chaffee Drive #101

    Titusville, FL 32780-7933

    sunwavesanitizer.com

  • Drug Facts

    Sanitizer Label 100mL 5item Alcohol

    Active Ingredient

    Alcohol 70% v/v

    Purpose

    Antiseptic

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    denatured dt ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75023-004
    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
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 26 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75023-004-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/05/2020
    2NDC:75023-004-02100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/05/2020
    3NDC:75023-004-03100 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product07/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/05/2020
    Labeler - SUN WAVE WELLNESS, LLC (117465590)
    Registrant - SUN WAVE WELLNESS, LLC (117465590)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUN WAVE WELLNESS, LLC117465590manufacture(75023-004)
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