Label: ALCIS DAILY RELIEF PAIN RELIEF- trolamine salicylate cream

  • 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 June 28, 2013

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  • ACTIVE INGREDIENT

    Active ingredients
    Trolamine Salicylate 10%    		Purpose
    Topical Analgesic
  • PURPOSE

  • INDICATIONS & USAGE

    Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises.

  • Warnings

    For External Use Only

  • ASK DOCTOR

    Ask a doctor before use if you have a propensity for allergic reactions to aspirin or salicylate. Before use on children under 2 years of age, consult a physician.

  • When using this product

    • Avoid direct contact with eyes or mucous membranes
    • Do not apply to wounds or damaged skin
  • STOP USE

    If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

  • PREGNANCY OR BREAST FEEDING

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center Immediately.

  • DOSAGE & ADMINISTRATION

    Directions-Massage a generous amount onto muscles, joints or affected area. Repeat as necessary, up to 3-4 times daily.

  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

    Inactive Ingredients: Camellia oleifera Leaf Extract, Caprylic/Capric/Myristic/Stearic Triglyceride, Chamomilla recutita (Matricaria) Flower Extract, Chamomilla recutita (Matricaria) Oil, Cyclomethicone, Cetyl Alcohol, Dimethicone, Dimethyl Sulfone, Disodium EDTA, Fragrance, Glucosamine Sulfate, Glyceryl Monostearate, Imidurea, Lavandula angustifol (lavender) Extract, Methylparaben, PEG-12 Glyceryl Distearate, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Rosmarinus officinalis (Rosemary) Oil, Sodium Metabisulfite, Stearyl Alcohol, Tocopheryl Acetate, Vitis vinifera (Grape) Seed Extract, Xanthan Gum

  • QUESTIONS

    Questions or comments? 1-800-977-8123
    www.alcis.com

  • SPL UNCLASSIFIED SECTION

    Manufactured in USA by Biozone Laboratories
    Distributed by ALCiS Topical, Inc., Santa Clara, CA 95051 Rev.

  • PRINCIPAL DISPLAY PANEL - 88.7 mL container

    NDC 58132-3331-02

    works in as little as 5 minutes

    ALCiS®
    THE SCIENCE OF RELIEF®

    DAILY RELIEF

    PAIN RELIEF CREAM

    engineered therapy
    for muscles and jointsTM

    with nourishing botanicals
    and antioxidants to rejuvenate skin

    2 fl oz / 59.15 ml

    Manufactured in USA by Biozone Laboratories
    Distributed by ALCiS Topical, Inc., Santa Clara, CA 95051 Rev.

    Trolamine Salicylate 10% Carton Image 1
  • INGREDIENTS AND APPEARANCE
    ALCIS DAILY RELIEF PAIN RELIEF 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58132-3331
    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
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    IMIDUREA (UNII: M629807ATL)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58132-3331-21 in 1 CARTON
    159.1 mL in 1 TUBE
    2NDC:58132-3331-31 in 1 CARTON
    288.7 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/09/2009
    Labeler - Alcis Topical, Inc. (078787365)
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