Label: DR. TEALS PRE AND POST WORKOUT PAIN RELIEF- menthol 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 December 28, 2015

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!