Label: ASPER-FLEX CREAM- 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 September 11, 2017

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

  • Drug Facts

    Active Ingredients...................................Purpose
    Trolamine Salicylate(10%).......................Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of
    muscles and joints associated with arthritis, simple backaches,
    strains and sprains.

  • Directions

    Apply generously to affected area. Massage
    into painful area until thoroughly absorbed into skin.
    Repeat as necessary, but not more than 4 times daily.

  • DOSAGE & ADMINISTRATION

    No more than 4 times daily.

  • Warnings

    • Use only as directed • If prone to allergic
    reaction from aspirin or salicylate, consult a doctor • If redness
    is present, discontinue use and consult a doctor • If
    condition worsens or if pain persists for more than 7 days
    or clears up and occurs again within a few days, discontinue
    use and consult a doctor • Avoid contact with eyes • As
    with any drug, if you are pregnant or nursing a baby, seek
    the advice of a health professional before using this product
    Do not use: • On children under 10 years of age • If
    skin is irritated or if irritation develops • KEEP THIS AND
    ALL MEDICINE OUT OF THE REACH OF CHILDREN • In
    case of accidental ingestion, seek professional assistance or
    contact a poison control center immediately

  • Other Ingredients

    Aloe Vera Gel, Alpha Tocopherol, Cetyl Alcohol, Glycerin, DMDM Hydantoin, Methylparaben, Mineral Oil, Propylene Glycol, Propylparaben, Stearic Acid, Triethanolamine, Water  

  • Storage

    At room temperature 15º-30º C (59º-86º F).
    Close cap tightly after use.

  • Keep out of reach of children

    KEEP THIS AND ALL MEDICINE OUT OF THE REACH OF CHILDREN

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASPER-FLEX   CREAM
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Trolamine Salicylate (UNII: H8O4040BHD) (salicylic acid - UNII:O414PZ4LPZ) Trolamine Salicylate8.5 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-010-0385 g in 1 TUBE; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/31/2015
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-010)