HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]

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  • HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]

HAND GEL PROLIM INSTANT HAND SANITIZER (ALCOHOL) GEL [PROLIM QUIMICA AVANCADA LTDA.]
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NDC 50414-100-01, 50414-100-02, 50414-100-03, 50414-100-04, 50414-100-05, 50414-100-06, 50414-100-07, 50414-100-08, 50414-100-09
Set ID 2c0441c7-96e9-4b2b-b851-527badd7429a
Category HUMAN OTC DRUG LABEL
Packager Prolim Quimica Avancada Ltda.
Generic Name
Product Class
Product Number
Application Number PART333
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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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