Label: SUN WAVE CONSUMER ANTISEPTIC HAND SANITIZER- isopropyl 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 April 10, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • 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 excessive heat above 40C (104F).
  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Sanitizer pkg001ANTISEPTIC

    HAND

    SANITIZER

    SPRAY GEL

    ALCOHOL ANTISEPTIC 70%

    enriched with aloe

    CLEAN SCENT

    TOPICAL SOLUTION

    KILLS

    GERMS &

    BACTERIA

    3.4OZ 100ML

    NO-STERILE SOLUTION

  • INGREDIENTS AND APPEARANCE
    SUN WAVE CONSUMER ANTISEPTIC HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75023-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 1 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 26 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75023-001-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2020
    Labeler - SUN WAVE WELLNESS, LLC (117465590)
    Registrant - SUN WAVE WELLNESS, LLC (117465590)
    Establishment
    NameAddressID/FEIBusiness Operations
    SUN WAVE WELLNESS LLC117465590manufacture(75023-001)
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