Label: 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 4, 2020

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    • wet hands thoroughly with product and allow to dry without wiping
    • for children under 6 use only under adult supervision
    • not recommended for infants
  • WARNINGS

    For External Use Only

    Flammable, keep away from fire or flame

  • INACTIVE INGREDIENT

    organic coconut oil, organic olive oil, organic jojoba oil, lavender essential oil, orange essential oil, cedarwood oil, rosemary extract, organic aloe vera.

  • INDICATIONS & USAGE

    • to decrease bacteria on the skin
    • recommended for repeated use
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • ACTIVE INGREDIENT

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • PRINCIPAL DISPLAY PANEL

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73770-810
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL41.3 mL  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M) 2 mL  in 59 mL
    COCONUT OIL (UNII: Q9L0O73W7L) 2 mL  in 59 mL
    OLIVE OIL (UNII: 6UYK2W1W1E) 2 mL  in 59 mL
    BITTER ORANGE OIL (UNII: 9TLV70SV6I) 0.6 mL  in 59 mL
    CEDAR LEAF OIL (UNII: BJ169U4NLG) 0.6 mL  in 59 mL
    SUNFLOWER OIL MONOGLYCERIDES (UNII: ZVW8EIZ3IE) 2 mL  in 59 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 3 mL  in 59 mL
    SHEA BUTTER (UNII: K49155WL9Y) 2 mL  in 59 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 59 mL
    LAVENDER OIL (UNII: ZBP1YXW0H8) 1 mL  in 59 mL
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.5 mL  in 59 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73770-810-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    2NDC:73770-810-05150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    3NDC:73770-810-04120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/2020
    Labeler - Mi Amore Skincare, LLC (108752174)