Label: DR GOLDSONS- menthol, methyl salicylatw 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 March 21, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients

    Menthol 8%

    Methyl Salicylate 30%

  • PURPOSE

    Menthol 8% ...............................External Analgesic

    Methyl Salicylate 30% ...............External Analgesic

  • INDICATIONS & USAGE

    INDICATIONS & USAGE SECTION

    Uses for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS

    Warnings

    For external use only

    Do not use

    - on wounds or damaged skin

    - with heating pad

  • STOP USE

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Direction

    - Use only as directed

    - Adults and children over 12 years: Apply to affected area no more than 3 to 4 times daily.

    - Children 12 years or younger: ask a doctor.

    - Close cap tightly after use.

  • INACTIVE INGREDIENT

    Curcuma Longa (Turmeric) Root Extract

    DEA-Cetyl Phosphate

    Glyceryl Stearate

    Glycerin

    Lanolin

    Potassium Stearate

    Stearic Acid

    Water

  • PRINCIPAL DISPLAY PANEL

    DR GOLDSON'S
    ​
    ​

  • INGREDIENTS AND APPEARANCE
    DR GOLDSONS 
    menthol, methyl salicylatw cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-009-01113.4 mL in 1 JAR; Type 0: Not a Combination Product04/17/2019
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/21/2019
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-009)
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