PAIN RELIEVING TOPICAL ANALGESIC (TROLAMINE SALICYLATE 10%) CREAM [TOP CARE]

PAIN RELIEVING TOPICAL ANALGESIC (TROLAMINE SALICYLATE 10%) CREAM [TOP CARE]
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NDC 36800-884-03
Set ID dd95db29-0be7-4b46-8631-62b58bd267c2
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient                               Purpose

    Trolamine Salicylate - 10%                Topical Analgesic

  • DOSAGE & ADMINISTRATION

    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 no more than 4 times daily Children 12 years or younger: ask a doctor.

  • PURPOSE

  • INDICATIONS & USAGE

    ​Uses ​temporarily reliefs minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps

  • WarningsFor external use only

    Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    ​When using this product • use only as directed • avoid taking a bath or shower within 1 hour before or after applying • do not bandage tightly or use with a heating pad • avoid contact with eyes or muscous 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 the children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Stearic Acid, Triethanolamine, Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING TOPICAL ANALGESIC 
    trolamine salicylate 10% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-884
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Mineral Oil (UNII: T5L8T28FGP)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-884-031 in 1 CARTON08/18/2014
    189 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/18/2014
    Labeler - Top Care (006935977)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(36800-884) , label(36800-884)

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