Label: ALOE VERA CENTER HAND SANITIZER- alcohol gel

  • NDC Code(s): 61577-1113-2, 61577-1113-4, 61577-1113-8
  • Packager: SOMBRA COSMETICS
  • 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 23, 2020

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

  • Active Ingredients

    Ethyl Alcohol 65%

  • Uses

    Helps reduce bacteria on the skin that could cause diseases.

  • Warnings

    Flammable. Keep away from fire or flame. For external use only.

  • Do not use

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • When Using

    When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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 in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

  • Other information

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (105F)

  • Inactive ingredients

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

  • Purpose

    Antiseptic, Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    Aloe Vera 8oz gel

  • INGREDIENTS AND APPEARANCE
    ALOE VERA CENTER HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61577-1113
    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)  
    ROSA DAMASCENA FLOWER (UNII: JWB78P295A)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    YUCCA SCHIDIGERA STEM (UNII: N59C6T6D72)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61577-1113-8236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    2NDC:61577-1113-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    3NDC:61577-1113-254 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - SOMBRA COSMETICS (097464309)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOMBRA COSMETICS097464309manufacture(61577-1113)