MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]

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MUSCLE (MENTHOL) GEL [WATER-JEL TECHNOLOGIES]
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NDC 59898-805-05, 59898-805-10, 59898-805-17, 59898-805-18, 59898-805-20, 59898-805-21, 59898-805-22, 59898-805-23, 59898-805-24, 59898-805-25
Set ID 1af399af-07b0-4899-9bcc-1e244b63b1cf
Category HUMAN OTC DRUG LABEL
Packager WATER-JEL TECHNOLOGIES
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active ingredient

    Menthol 3.5%

  • Purpose

    External analgesic

  • Uses

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

  • 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

  • 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
  • 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
  • Inactive ingredients

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

  • Questions?

    1-800-275-343 info@waterjel.com www.waterjel.com

    Manufactured by Water-Jel Technologies Inc.

    50 Broad Street, Carlstadtn NJ 07072 USA

  • Principal Display Panel

    MJ16

  • INGREDIENTS AND APPEARANCE
    MUSCLE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ANGELICA ARCHANGELICA ROOT (UNII: DTN01M69SN)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59898-805-171728 in 1 CARTON04/19/2010
    13.8 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59898-805-185 in 1 BOX, UNIT-DOSE04/19/2010
    23.8 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:59898-805-0596 in 1 BOX, UNIT-DOSE04/19/2010
    33.8 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:59898-805-2024 in 1 CARTON04/19/2010
    43.8 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:59898-805-243784 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
    6NDC:59898-805-21473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
    7NDC:59898-805-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/17/2013
    8NDC:59898-805-23946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/19/2010
    9NDC:59898-805-2280 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/19/2010
    10NDC:59898-805-25118 mL in 1 TUBE; Type 0: Not a Combination Product04/19/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/19/2010
    Labeler - WATER-JEL TECHNOLOGIES (155522589)
    Establishment
    NameAddressID/FEIBusiness Operations
    WATER-JEL TECHNOLOGIES155522589manufacture(59898-805)
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