MYOFLEX (TROLAMINE SALICYLATE) CREAM [DR. REDDY'S LABORATORIES INC.]

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MYOFLEX (TROLAMINE SALICYLATE) CREAM [DR. REDDY'S LABORATORIES INC.]
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NDC 55741-304-04
Set ID 8eb6bb79-46c0-4cc2-a81a-fb3203b8c97f
Category HUMAN OTC DRUG LABEL
Packager Dr. Reddy's Laboratories Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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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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