Label: THERAGESIC CREME- methyl salicylate 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 April 14, 2021

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  • ACTIVE INGREDIENT

    Drug Facts

    Active IngredientsPurpose
    Menthol 1%............................................................................................................................................................................................................................................................................................................................................................................... Analgesic
    Methyl Salicylate 15%......................................................................................................................................................................................................................................................................................................................................................... Counterirritant
  • PURPOSE

    Use

    temporary relief of minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backaches
    • strains
    • bruises
    • sprains
  • WARNINGS

    Warnings

    For external use only. Use only as directed. Avoid contact with eyes or mucous membranes.

    Do not bandage, wrap, cover, use a heating pad after, or recline upon skin treated with THERA-GESIC ®.

  • DO NOT USE

    Do not use

    • immediately shower or bath
    • if skin is sensitive to oil of wintergreen (methyl salicylate)
    • on wounds or damaged skin
  • ASK DOCTOR

    Ask a doctor before use

    • for children under 2 and to 12 years of age
    • if prone or sensitive to allergic reaction from aspirin or salicylate
  • WHEN USING

    When using this product

    • discontinue use if skin irritation develops, or redness is present
    • do not swallow
    • do not use a heating pad after application of THERA-GESIC ®
  • STOP USE

    Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE FORMS & STRENGTHS

    Directions

    Adults and children 12 or more years of age. Apply thin layers of crème into and around the sore or painful area, not more than 3 to 4 times daily. The number of thin layers controls the intensity of the action of THERA-GESIC ®. One this layer provides a mild effect, two thin layers provide a strong effect and three thin layers provide a very strong effect. SEE WARNINGS. Wash hands thoroughly after application.

  • INDICATIONS & USAGE

    Other information

    Showering or washing the area after application of THERA-GESIC ® will leave the area fragrance-free without diminishing the therapeutic effect. Avoid contact with clothing or other surfaces. Store at 20-25°C (68-77°F).

  • INACTIVE INGREDIENT

    Inactive ingredients

  • QUESTIONS

    Questions (210) 696-8400 (M-Th 8:00-5:30 CST)

  • PRECAUTIONS

    SHARE BEFORE USE: IT IS NORMAL FOR THIS PRODUCT TO GIVE THE IMPRESSION OF A LIQUID SOUND UON SHAKING. DO NOT ALLOW THERA-GESIC ® TO COMEIN CONTACT WITH ANY SURFACE, OTHER THAN SKIN.

    Do not use this product if tube is punctured. Lot number and expiration date on end of carton.

    MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355

    50588 03 Rev 001090




  • DOSAGE & ADMINISTRATION

  • WARNINGS AND PRECAUTIONS

  • THERA-GESIC 5-oz

    Product: 50090-0430

    NDC: 50090-0430-0 85 g in a TUBE / 1 in a CARTON

  • METHYL SALICYLATE

    Label Image
  • INGREDIENTS AND APPEARANCE
    THERAGESIC CREME 
    methyl salicylate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0430(NDC:0178-0320)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0430-01 in 1 CARTON11/28/2014
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/1981
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0430)
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