Label: ENCHANTMENT HAND SANITIZER- alcohol gel

  • 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 November 6, 2020

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  • Active Ingredients

    Alcohol 65%

  • Uses

    Helps reduce bacteria on the skin that potentially can cause disease.  For use when soap and water are not available.

  • Warnings

    Flammable. Keep away from heat and flame. For external use only.

  • Do not use

    In children less than 2 months of age.  On open skin wounds

  • When Using

    When using this product, keep out of eyes, ears and mouth.  In case of contact with eyes, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • Storage

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, citrus limon (lemon) peel oil, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract,  rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, filipendula ulmaria (queen of the prairie) extract, camellia sinensis (green tea) leaf extract, aloe barbadensis leaf extract.

    *organic

  • Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    Enchantment 2g gel

  • INGREDIENTS AND APPEARANCE
    ENCHANTMENT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LEMON PEEL (UNII: 72O054U628)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
    FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-1119-22 mL in 1 PACKET; Type 0: Not a Combination Product07/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/29/2020
    Labeler - SOMBRA COSMETICS (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-1119)
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