Label: DR. DS SUPER 7 PAIN RELIEF- menthyl salicylate and menthol cream

  • NDC Code(s): 72246-112-01
  • Packager: Promedx Innovations Inc
  • 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 January 27, 2021

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  • Drug Facts

  • Active Ingredient

    Menthyl Salicylate 10%

    Menthol 2%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

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

    For external use only

    Allergy alert

    • do not use if you are allergic to plants of the Asteraceae / Compositae / Daisy family

    When using this product

    • avoid contact with the eyes and mucous membranes
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not apply with external heat, such as an electric pad, as this may result in excessive skin irritation or skin burn

    Ask a healthcare professional before use if you are

    • taking anticoagulant medications

    Stop using and ask a healthcare professional if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • if a rash develops, or you become hypersensitive and/or burning, blistering or swelling occurs, discontinue use and seek medical help immediately

    If pregnant or breast-feeding

    • ask a healthcare professional before use

    Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    Adults and children 2 years of age and older:

    • shake bottle before use
    • apply a thin and even coat to affected area not more than 3 to 4 times daily
    • rub and/or massage into skin until the preparation disappears

    Children (2 to 12 years old)

    • ask a doctor
    • application should be supervised by an adult
  • Other information

    • store at room temperature 15°C - 30°C (59°F - 86°F)
    • do not use if quality seal is missing or broken
    • store in airtight, light-resistant container
  • Inactive ingredients

    Arnica Montana Flower Extract, Benzoic Acid, Brassica Campestris (Rapeseed) Seed Oil, Citric Acid, Dehydroacetic Acid, Eucalyptus Globulus Leaf Essential Oil, Glycerin, Linum Usitatissimum (Linseed) Seed Extract, MSM, Myristyl Myristate, Neopentyl Glycol Dicaprylate/Dicaprate, Peppermint Oil (Mentha piperita), Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Stearoyl Glutamate, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    DR. D'S

    SUPER 7

    Enhanced Topical Pain Relief

    NEW

    For relief of:

    Muscle, Joint

    and Arthritic Pain

    TRIPLE CARRIER SYSTEM

    • Doctor Developed
    • 7 Powerful Natural Ingredients
    • Easy to Use Applicator
    • Paraben and PEG Free

    88 mL

    NDC 72246-112-01

    ProMedx-Dr.-D's-Super-7-US-88-ml-01

  • INGREDIENTS AND APPEARANCE
    DR. DS SUPER 7 PAIN RELIEF 
    menthyl salicylate and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72246-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ROSEMARY (UNII: IJ67X351P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FLAX SEED (UNII: 4110YT348C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72246-112-011 in 1 CARTON09/04/2019
    188 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/04/2019
    Labeler - Promedx Innovations Inc (203749853)
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