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ULTRACIN (Cal Pharma)

Available Formats

Dosage Form Package Information Links
LOTION 120 mL in 1 TUBE (55628-9179-4) Label Information

Complete ULTRACIN Information

  • 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

    Aloe Barbadensis (Aloe) Leaf Juice,Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Boswelia Serrata Extract, Butterbur Extract,Cetearyl Alcohol and Polysorbate 60, Glyceryl Stearate and PEG 100 Stearate, Hydroxypropyl Methylcellulose,Isopropyl Myristate, Isopropyl Palmitate, Methylisothiazolinone, Phenoxyethanol and Ethylhexylglycerin,Pine Bark Extract, Polaxamer, Prickly Ash Extract, Propylene Glycol, Sichuan Peppercorn Extract, Soya Lecithin, Stearyl Alcohol, Water, Willowbark Extract, Wintergreen Extract, Zingiber Ocinale Root Extract


  • INGREDIENTS AND APPEARANCE
    ULTRACIN 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55628-9179
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 10 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 28 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 25 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    TUSSILAGO FARFARA LEAF (UNII: G2GH7V846Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ZANTHOXYLUM BUNGEANUM WHOLE (UNII: WH9894JM8K)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    WILLOW BARK (UNII: S883J9JDYX)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55628-9179-4 120 mL in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:55628-9179-1 30 mL in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:55628-9179-2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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)
    Registrant - Cal Pharma (078721283)