Label: SCREAMIN MENTHOL TOAST  - menthol cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

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

  • ACTIVE INGREDIENT


    Active Ingredient Purpose
    Menthol 4%..........................Topical analgesic

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  • PURPOSE

    Uses temporarily relieves minor body aches and pains due to:  ar thritis pain, back pain, muscle aches,joint pain.
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  • WARNINGS

    Warnings for external use only

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  • DO NOT USE

    Do not use immediately before or after bathing or using a hot tub, in conjunction with heating pad,under wrapping or bandage where perspiration is likely to occur.

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  • ASK DOCTOR

    Stop use and ask doctor if excessive irritation occurs, if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

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  • WHEN USING

    When using this product avoid contact with eyes, mucous membranes, open wounds, cuts, abrasions and where skin touches skin, perspiration may increase the sensation of heat, rinse eyes with cold water if irritated.

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  • STOP USE

    Stop use and ask doctor if excessive irritation occurs, if condition worsens ,if symptoms persist for more than 7 days or clear up and occur again within a few days.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • INDICATIONS & USAGE

    Directions apply a suitable amount of product to the region of specific pain or injury, avoiding sensitive areas reapply up to three times per daily, wash hands thoroughly in the event of contact. First time users should apply a small amount and increase gradually on reapplications depending on reaction. For use on children under the age of 12 consult a physician Arthritis suf ferers: Apply three times daily for two weeks. Wait twenty minutes before washing arthritic hands. Thereafter use as needed.

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  • SAFE HANDLING WARNING

    Other information
    Store at room temperature

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  • INACTIVE INGREDIENT

    Inactive ingredients
    Boswellia Carterii Resin Extract, Capsicum Annuum Resin, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Isopropyl Alcohol, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Leaf Oil, Propylene Glycol, Triethanolamine, Water (Aqua)

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  • QUESTIONS

    Questions or comments:
    1-800-4NO-PAIN,
    toastproducts.com
    MFD FOR: Toast Products
    400 Sproul Street,
    Pittsburgh, PA 15136
    MFG IN USA

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  • DOSAGE & ADMINISTRATION

    apply to the region of specific pain or injury

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  • INGREDIENTS AND APPEARANCE
    SCREAMIN MENTHOL TOAST  
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52099-8010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    CHAMOMILE  
    ISOPROPYL ALCOHOL  
    POLYSORBATE 80  
    METHYLPARABEN  
    FRANKINCENSE  
    CAPSICUM OLEORESIN  
    PROPYLENE GLYCOL  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
    ROSEMARY OIL  
    WATER  
    TROLAMINE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52099-8010-1 141 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 06/21/2012
    Labeler - Q.A. Laboratories (065361149)
    Registrant - Q.A. Laboratories (065361149)
    Establishment
    Name Address ID/FEI Business Operations
    Q.A. Laboratories 065361149 manufacture(52099-8010)
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