Label: ULTRA THERAPY PAIN RELIEF- menthol, methyl salicylate and capsaicin lotion 

  • Label RSS
  • 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 06/13

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  • ACTIVE INGREDIENT

    METHYL SALICYLATE (28%)

    MENTHOL (10%)

    CAPSAICIN (0.025%)

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  • PURPOSE

    TOPICAL ANALGESIC

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  • INDICATIONS & USAGE

    USE

    - TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

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  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

    DO NOT USE ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN AS WELL AS IN THE EYES, MOUTH, GENITALS OR OTHER MUCOUS MEMBRANE

    STOP USE AND CONSULT YOUR PHYSICIAN IF PAIN IS PERSISTENT OR WORSENS

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    - APPLY ON CLEAN SKIN AND GENTLY RUB OVER AREA WITH PAIN. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED AND RUBBED ONTO SKIN.

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Butterbur Extract, Cetearyl Alcohol and Polysorbate 60, Glucosamine HCl, Glyceryl Stearate and Peg 100 Stearate, Hydroxypropyl Methylcellulose, Isopropyl Palmitate, Phenoxyethanol, Ethylhexylglycerin, Pine Bark Extract, Prickly Ash Bark Extract, Propylene Glycol, Sichuan Peppercorn Extract , Stearyl Alcohol, Water Deionsed, Willowbark Extract, Wintergreen Extract

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  • INGREDIENTS AND APPEARANCE
    ULTRA THERAPY PAIN RELIEF 
    menthol, methyl salicylate, capsaicin lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:55628-1001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 10 g  in 100 mL
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 28 g  in 100 mL
    CAPSAICIN (CAPSAICIN) CAPSAICIN .025 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    PETASITES HYBRIDUS LEAF  
    CETOSTEARYL ALCOHOL  
    POLYSORBATE 60  
    GLUCOSAMINE HYDROCHLORIDE  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    HYPROMELLOSES  
    ISOPROPYL PALMITATE  
    PHENOXYETHANOL  
    ETHYLHEXYLGLYCERIN  
    MARITIME PINE  
    ZANTHOXYLUM AMERICANUM BARK  
    PROPYLENE GLYCOL  
    ZANTHOXYLUM BUNGEANUM WHOLE  
    STEARYL ALCOHOL  
    WATER  
    WILLOW BARK  
    GAULTHERIA PROCUMBENS LEAF  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55628-1001-2 120 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 11/29/2012
    Labeler - Cal Pharma (078721283)
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