Label: MUSCLE - menthol gel

  • NDC Code(s): 59898-805-05, 59898-805-10, 59898-805-17, 59898-805-18, view more
    59898-805-20, 59898-805-21, 59898-805-22, 59898-805-23, 59898-805-24, 59898-805-25
  • Packager: WATER-JEL TECHNOLOGIES
  • 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 03/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Menthol 3.5%

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  • Purpose

    External analgesic

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  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

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  • Warnings

    For external use only

    When using this product

    • avoid contact with the eyes
    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • conditions worsens
    • symptoms persist for more than 7 days
    • condition clears up and occurs again within a few days

    Keep out of the reach of children

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

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  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
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  • Other information

    • store at room temperature
    • apply product directly onto sore areas of the body
    • massage well for best results
    • following application, wash hands well and rinse with cool water
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  • Inactive ingredients

    aloe barbadensis leaf juice, angelica archangelica root extract, camphor, carbomer, DMDM hydantoin, isopropyl alcohol, methylparaben, panax ginseng root extract, purified water, triethanolamine

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  • Questions?

    1-800-275-343

    info@waterjel.com   www.waterjel.com

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    MUSCLE  
    menthol gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59898-805
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ISOPROPYL ALCOHOL  
    ANGELICA ARCHANGELICA ROOT  
    ASIAN GINSENG  
    ALOE VERA LEAF  
    CARBOMER HOMOPOLYMER TYPE C  
    TROLAMINE  
    DMDM HYDANTOIN  
    METHYLPARABEN  
    CAMPHOR (NATURAL)  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59898-805-17 1728 in 1 CARTON
    1 3.8 mL in 1 PACKET
    2 NDC:59898-805-18 5 in 1 BOX, UNIT-DOSE
    2 3.8 mL in 1 PACKET
    3 NDC:59898-805-05 96 in 1 BOX, UNIT-DOSE
    3 3.8 mL in 1 PACKET
    4 NDC:59898-805-20 24 in 1 CARTON
    4 3.8 mL in 1 PACKET
    5 NDC:59898-805-24 3784 mL in 1 BOTTLE, PUMP
    6 NDC:59898-805-21 473 mL in 1 BOTTLE, PUMP
    7 NDC:59898-805-10 59 mL in 1 BOTTLE, SPRAY
    8 NDC:59898-805-23 946 mL in 1 BOTTLE, PUMP
    9 NDC:59898-805-22 80 mL in 1 BOTTLE, DISPENSING
    10 NDC:59898-805-25 118 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/19/2010
    Labeler - WATER-JEL TECHNOLOGIES (155522589)
    Establishment
    Name Address ID/FEI Business Operations
    WATER-JEL TECHNOLOGIES 155522589 manufacture(59898-805)
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