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

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 December 22, 2020

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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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