ULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]

  • Home
  • ULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]

ULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]
PDF | XML
NDC 55628-1001-2
Set ID 3d42ba94-0a53-4cc2-bda4-a4284c28c974
Category HUMAN OTC DRUG LABEL
Packager Cal Pharma
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • ACTIVE INGREDIENT

    METHYL SALICYLATE (28%)

    MENTHOL (10%)

    CAPSAICIN (0.025%)

  • PURPOSE

    TOPICAL ANALGESIC

  • INDICATIONS & USAGE

    USE

    - TEMPORARILY RELIEVES MILD ACHES AND PAINS OF MUSCLE AND JOINTS

  • 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

  • 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.

  • 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Therapy Gels_Pain_20130423

  • INGREDIENTS AND APPEARANCE
    ULTRA THERAPY PAIN RELIEF 
    menthol, methyl salicylate, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE28 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.025 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ZANTHOXYLUM BUNGEANUM WHOLE (UNII: WH9894JM8K)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    WILLOW BARK (UNII: S883J9JDYX)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55628-1001-2120 mL in 1 TUBE; Type 0: Not a Combination Product11/29/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/29/2012
    Labeler - Cal Pharma (078721283)
View All Sections

Related Drugs

Search DailyMed Drugs