Label: REED THERAPEUTICS PAIN RELIEVING THERAPY- methyl salicylate, menthol usp, camphor gel

  • 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 January 9, 2013

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  • Drug Facts

    Active Ingredient, Purpose

    Methyl Salicylate 12.5%, Topical Analgesic/Anti-Inflammatory

    Methol USP 4%, Topical Analgesic

    Camphor 0.2%, Topical Analgesic, Anti-Inflammatory

  • Uses

    Temporary relief of minor aches and pains of sore muscles and joints associated with: arthritis, backache, bursitis, muscle cramps, muscle strain and sprains, plantar fasciitis, tendonitis

  • Warnings

    For external use only. Keep away from excessive heat or open flame.

    If pregnant or breast-feeding: Ask healthcare professional before use.

  • Keep out of reach of children

    If accidently ingested, seek medical help or contact a Poison Control Center immediately.

  • When using this product

    When using this product:

    Avoid contact with eyes or mucous membranes

    Do not apply to wounds or damaged skin

    Do not bandage

    Do not use with heating pad or device

    Do not use with other ointments, creams, sprays, or liniments

    Stop use and ask a doctor if

    Stop use and ask a doctor if:

    Condition worsens or if symptoms persist for more than 7 days

    Symptoms clear up and occur again within a few days

    Excessive skin irritation occurs

  • Directions

    Adults and children 12 years and older: Gently massage and apply to affected area 3-4 times daily. Massage not necessary but may enhance relief.

    Children under 12 years of age: Consult a physician.

  • Other Information

    Sore at controlled room temperature 68° to 77° F. Close cap after use.

  • Inactive Ingredients

    Carbomer 940, DMDM Hydantoin, FD&C Blue #1, Paraguariensis Extract, Methylparaben, Propylparaben, Tea Tree Oil, Thyme Oil, Triethanolamine, Water (D.I.), FD&C Yellow #5

  • PRINCIPAL DISPLAY PANEL

    package label.principal display panel

  • INGREDIENTS AND APPEARANCE
    REED THERAPEUTICS PAIN RELIEVING THERAPY 
    methyl salicylate, menthol usp, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76437-609
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE12.5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ILEX PARAGUARIENSIS WHOLE (UNII: QJB02841ZY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    THYME OIL (UNII: 2UK410MY6B)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76437-609-05150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/09/2013
    Labeler - Reed Therapeutics (032505137)
    Registrant - Geritrex (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex112796248manufacture(76437-609)
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