Label: ANALGESIC- trolamine salicylate cream

  • NDC Code(s): 41250-251-21
  • Packager: Meijer Distribution Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/09

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  • Active ingredient

    Trolamine salicylate 10%

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  • Purpose

    Topical analgesic

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  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
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  • Warnings

    For external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with the eyes or mucous membranes
    • do not apply to wounds or damaged skin

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    adults and children over 12 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but not more than 4 times daily

    children 12 years or younger: ask a doctor

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  • Other information

    • store at 20°-25°C (68°-77°F)
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  • Inactive ingredients

    aloe barbadensis leaf juice, dimethicone, edetate disodium, glyceryl monostearate, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sorbitol solution

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  • Principal Display Panel

    ASPIRIN FREE

    Temporary Minor Arthritis, Joint & Muscle Pain Relief

    Analgesic Cream Rub

    pain relieving cream - with aloe

    Trolamine Salicylate, 10% - Odor Free Therapy

    COMPARE TO ASPERCREME® active ingredient

    Analgesic Cream Rub Carton Image 1

    Analgesic Cream Rub Carton Image 1

    Analgesic Cream Rub Carton Image 2

    Analgesic Cream Rub Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    trolamine salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:41250-251
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TROLAMINE SALICYLATE (TROLAMINE) TROLAMINE SALICYLATE 10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    EDETATE DISODIUM  
    METHYLPARABEN  
    PROPYLPARABEN  
    WATER  
    DIMETHICONE  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    PROPYLENE GLYCOL  
    SORBITOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-251-21 1 in 1 CARTON
    1 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 04/15/1990
    Labeler - Meijer Distribution Inc (006959555)
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