DR. TEALS PRE AND POST WORKOUT PAIN RELIEF (MENTHOL) CREAM [PDC BRANDS]

DR. TEALS PRE AND POST WORKOUT PAIN RELIEF (MENTHOL) CREAM [PDC BRANDS]
PDF | XML

NDC 61012-010-01, 61012-010-57
Set ID 4346db64-6433-4815-aaa2-623a15d7920a
Category HUMAN OTC DRUG LABEL
Packager PDC Brands
Generic Name
Product Class
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    ​Drug Facts

  • Active ingredients

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves the minor aches and pains of muscles and joints associated with:

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

    ​For external use only

  • Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • Ask a doctor before use if you have

    • redness over the affected area
  • When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • excessive skin irritation occurs
  • 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 immediately.

  • Directions

    • Use only as directed
    • ​Adults and children 12 years of age and older:

    Apply a thin layer to affected area not more than 3 to 4 times daily, allowing minimum of 2-3 hours in between applications.

    • ​Children under 12 years of age: ​ask a doctor
  • Other information

    • Store between 20° and 25°C (68° and 77°F)
  • Inactive ingredients:

    Cetearath 20, Cetyl Alcohol, Cetyl Ester, Ethylhexylglycerin, Fragrance(Parfum), Glycerin, Glyceryl Stearate SE, Isopropyl Palmitate, Magnesium Sulfate (Epsom Salt), Phenoxyethanol, Polyquaternium 37, PPG-1 Trideceth-6, Propylene Glycol Dicaprylate/Dicaprate, Simethicone, Stearic Acid, Stearyl Alcohol, Triethanolamine, Water (Aqua).

  • Principal Display Panel Dr. Teal's Pre & Post Workout Pain Relief Cream 2 oz./57g NDC: 61012-010-57

    Label1.jpg Label1 Label2.jpg Label2

  • INGREDIENTS AND APPEARANCE
    DR. TEALS  PRE AND POST WORKOUT PAIN RELIEF
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61012-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61012-010-011 in 1 CARTON
    1NDC:61012-010-5757 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 finalpart34802/10/2015
    Labeler - PDC Brands (037512746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories, LLC016754201manufacture(61012-010)

Related Drugs