Label: HAND SANITIZER WITH MOISTURIZERS AND ALOE VERA MODESA- 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 January 15, 2021

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  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Warnings

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

  • When using this product

    ■ do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • Stop use and aska doctor if

    ■ irritation or rash appears and lasts

  • Keep out of reach of children

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

  • Directions

    ■ place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. ■ children under 6 years of age should be supervised when using this product

  • Other information

    ■ store below 106ºF (41ºC) ■ may discolor certain fabrics or surfaces

  • Inactive ingredients

    water, glycerin, propylene glycol, acrylates/c10-30 alkyl acrylate crosspolymer, isopropyl alcohol,aminomethylpropanol, isopropyl myristate, caprylyl glycol, phenoxyethanol, fragrance, tocopheryl acetate, aloe barbedensis leaf juice, FD&C yellow no. 5, FD&C blue no. 1

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WITH MOISTURIZERS AND ALOE VERA  MODESA
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-432
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-432-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/19/2017
    2NDC:55319-432-331000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/19/2017
    3NDC:55319-432-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/19/2017
    Labeler - Family Dollar Services Inc. (024472631)
    Registrant - Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (533151022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil533151022manufacture(55319-432)
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