Label: HAND GEL PROLIM INSTANT 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 February 15, 2010

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  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • Recommended for aseptic hand cleansing. This product does not replace the use of soap and water.
    • Recommended for repeated use.
  • Warnings

    For external use only

  • When using this product

    • Keep out of eyes. In case of accidental contact, flush eyes thoroughly with water for 15 minutes.
    • Avoid contact with broken skin or you have allergies to any ingredients.
  • STOP USE

    Stop use and consult a doctor if skin irritation occurs.

  • Keep out of reach of children

    • In case of accidental ingestion drink plenty of water and seek medical help or contact a Poison Controll Center immediately.
    • External use only.
  • SPL UNCLASSIFIED SECTION

    FLAMMABLE: Keep out of heat.

  • Directions

    • Place a small amount of product in your hand.
    • Rub hands together briskly for at least 30 seconds until dry.
    • Children under 6 years of age should use under adult supervision.
  • Inactive Ingredients

    Water, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol,  Carbomer, DDM Hydantoin, Aminomethyl Propanol, Fragrance.

  • Questions?

    555-555-5555

  • Principal Display Panel

    image of label - bottle

    HAND GEL PROLIM
    INSTANT HAND SANITIZER
    Kills 99,99% of most commom germs
    2.7 OZ FL (80ml)

  • INGREDIENTS AND APPEARANCE
    HAND GEL PROLIM INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50414-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol0.7 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50414-100-0160 mL in 1 BOTTLE, PLASTIC
    2NDC:50414-100-0280 mL in 1 BOTTLE, PLASTIC
    3NDC:50414-100-03100 mL in 1 BOTTLE, PLASTIC
    4NDC:50414-100-04200 mL in 1 BOTTLE, PUMP
    5NDC:50414-100-05500 mL in 1 BOTTLE, PUMP
    6NDC:50414-100-061000 mL in 1 BOTTLE, PUMP
    7NDC:50414-100-075000 mL in 1 BOTTLE, PLASTIC
    8NDC:50414-100-081 in 1 BOX
    8800 mL in 1 BAG
    9NDC:50414-100-091 in 1 BOX
    91200 mL in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/10/2010
    Labeler - Prolim Quimica Avancada Ltda. (907224518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prolim Quimica Avancada Ltda.907224518manufacture
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