Label: HAND SANITIZER FIG RHUBARB- isopopyl alcohol 70% v/v 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 January 25, 2021

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  • ACTIVE INGREDIENT

    Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

  • USES:

    Effective indestroying(harmful) bacteria to provide antseptic cleansing recommeded for repeated use .

  • WARNINGS

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

  • DO NOT USE

    On children less than 2 months of age

    On open skin wounds

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and lasts for more than 72 hours.

  • WHEN USING

    • Avoid contact with eyes
    • If contact occure
    • Rinse thoroughly with water.

  • STORAGE AND HANDLING

    Do not store above 105F(41 C)

  • 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

  • INACTIVE INGREDIENT

    Water, Ricinus Communis Seed oil, Acrylates copolymer, Glycerin,Aloe Vera Juice, Isopropyl Myristate, Tococpheryl Acetate,Triethanolamine

    Parfum

  • DOSAGE & ADMINISTRATION

    • Rub thoroughly into hands for at least 30 seconds.
    • Allow to dry
    • For children under 6, use only under adult supervision.
    • Not recommended for infants.
  • PURPOSE

    Antiseptic , Hand Sanitizer

  • PRINCIPAL DISPLAY PANEL

    2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  FIG RHUBARB
    isopopyl alcohol 70% v/v gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81451-002
    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
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81451-002-0140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/25/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/25/2021
    Labeler - Pame Eco Tech (204258441)
    Registrant - Pame Eco Tech (204258441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pame Eco Tech204258441manufacture(81451-002)
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