Label: HIELO ARDIENTE- menthol gel

  • NDC Code(s): 53145-002-01
  • Packager: Menper Distributors, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 1%

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  • PURPOSE

    Purpose

    Analgesic

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  • INDICATIONS & USAGE

    Warnings

    • For external use only
    • Do not use if condition worsens
    • If symptoms persist for more than 5 days or recur, discontinue use and consult a physician
    • Do not apply to open wounds or damaged skin
    • Do not bandage tightly
    • Do not use with heating pads or heating devices
    • Avoid contact with eyes
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  • WARNINGS

    Use only as directed

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, contact a doctor or a Poison Control Center right away.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 12 years of age or older: Apply to affected area no more than 3 to 4 times daily. Children under 12 years of age, consult a physician
    • Cleanse and dry skin. May be used with wet or dry bandages in conjuction with ice packs.
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  • OTHER SAFETY INFORMATION

    Other information

    • store this product between 15°-30°C (59°-86°F)
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  • INACTIVE INGREDIENT

    Inactive ingredients

    camphor, carbomer 940, FD&C blue #1, isopropyl alcohol, methylchloroisothiazolinone, polysorbate 20, purified water, triethanolamine

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  • INGREDIENTS AND APPEARANCE
    HIELO ARDIENTE 
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53145-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 4840 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    CAMPHOR (SYNTHETIC)  
    CARBOMER 940  
    FD&C BLUE NO. 1  
    ISOPROPYL ALCOHOL  
    METHYLCHLOROISOTHIAZOLINONE  
    POLYSORBATE 20  
    WATER  
    TRIETHANOLAMINE BENZOATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53145-002-01 1 in 1 CARTON
    1 484 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 02/21/2012
    Labeler - Menper Distributors, Inc. (101947166)
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