Label: MYOFLEX- 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 15, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Trolamine salicylate 10%

  • Purpose

    Pain relieving cream

  • Use

    • temporarily relieves minor aches and pains of muscles and joints due to arthritis, strains and sprains, and simple backache
  • Warnings

    For external use only

    Do not use

    • in or near eyes
    • on wounds or damaged skin

    Stop use and ask a doctor if

    • condition lasts or gets worse
    • symptoms last more than 7 days or clear up and occur again within a few days

    If you are pregnant or breast-feeding, ask a health care professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • do not use more than directed
    • adults and children 2 years and older
      • apply to affected area not more than three to four times a day
      • may be covered with a sterile bandage
    • children under 2 years: ask a doctor
  • Other information

    • store at controlled room temperature 20-25°C (68-77°F)
    • close cap tightly
  • Inactive ingredients

    aloe vera gel, cetyl alcohol, glycerin, DMDM hydantoin, methylparaben, propylparaben, mineral oil, stearic acid, triethanolamine, purified water

  • Questions?

    call 1-800-790-6417

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Box

    NDC 55741-304-04

    up to 8 - Hour Formula

    MYOFLEX®
    PAIN RELIEVING CREAM

    TROLAMINE SALICYLATE 10%

    Targeted Relief From Minor Backache, Arthritis, Muscle & Joint Pain

    ✓ Deep Penetrating      ✓ Odorless      ✓ Pharmacist Recommended

    NET WT. 4 oz (113 g)

    Principal Display Panel - 113 g Tube Box
  • INGREDIENTS AND APPEARANCE
    MYOFLEX 
    trolamine salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-304
    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)  
    DMDM hydantoin (UNII: BYR0546TOW)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    mineral oil (UNII: T5L8T28FGP)  
    stearic acid (UNII: 4ELV7Z65AP)  
    trolamine (UNII: 9O3K93S3TK)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-304-041 in 1 BOX05/24/2016
    1113 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 finalpart34805/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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