Label: ULTRACIN T- trolamine salicylate 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

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  • ACTIVE INGREDIENTS

    TROLAMINE SALICYLATE 10%

  • PURPOSE

    TOPICAL ANALGESIC

  • USE:

    TEMPORARILY RELIEVES MILD ACHES, PAINS, AND INFLAMMATION OF MUSCLE AND JOINTS ASSOCIATED WITH WITH NERVE DAMAGE AND SPORT INJURIES

  • 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.

  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST FEEDING, ASK A HHEALTHCARE PROFESSIONAL BEFORE USE.

  • DIRECTIONS

    ADULTS AND CHILDREN OVER 12 YEARS: APPLY TO AFFECTED AREA AND GENTLY MASSAGE OVER AREA UNTIL ABSORBED. DO NOT USE MORE THAN 4 TIMES A DAY. WASH HANDS AFTER LOTION IS APPLIED.

  • INACTIVE INGREDIENTS

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe) Leaf Juice, Benzoic Acid, Boswellia Serrata Gum, Cetearyl Alcohol, Ethylhexylglycerin, Gaultheria Procumbens (Wintergreen) Leaf Extract, Glycereth-2 Cocoate, Glyceryl Stearate, Hydroxypropyl Methyl Cellulose, Isopropyl Palmitate, Peg-100 Stearate, Petasites Vulgaris( Butterbur) Leaf Extract, Phenoxyethanol, Pinus Pinaster Bark Bud Extract, Polysorbate 60, Propylene Glycol, Salix Alba (Willow) Bark Extract, Stearyl Alcohol, Water, Zanthoxylum Americanum( Prickly Ash) Bark Extract, Zingiber Officinale (Ginger) Root Extract

  • PRINCIPAL DISPLAY PANEL

    Ultracin T green copy

  • INGREDIENTS AND APPEARANCE
    ULTRACIN T 
    trolamine salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55628-9047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PETASITES HYBRIDUS LEAF (UNII: JOS311ZC1G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WILLOW BARK (UNII: S883J9JDYX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55628-9047-4120 mL in 1 TUBE; Type 0: Not a Combination Product08/04/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/04/2015
    Labeler - Cal Pharma (078721283)
    Registrant - Cal Pharma (078721283)
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