Label: ULTRACIN- methyl salicylate, menthol, capsaicin lotion

  • 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 November 23, 2019

If you are a consumer or patient please visit this version.

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

    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

  • PRINCIPAL DISPLAY PANEL

    Ultracin _REV01

  • INGREDIENTS AND APPEARANCE
    ULTRACIN 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9179
    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) CAPSAICIN25 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55628-9179-4120 mL in 1 TUBE; Type 0: Not a Combination Product11/29/2012
    2NDC:55628-9179-130 mL in 1 TUBE; Type 0: Not a Combination Product11/29/2012
    3NDC:55628-9179-260 mL in 1 BOTTLE; 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)
    Registrant - Cal Pharma (078721283)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!