Label: SCREAMIN HOT TOAST- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL

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 17, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient Purpose
    Capsaicin 0.03%...................Topical analgesic

  • PURPOSE

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

  • WARNINGS

    Warnings for external use only

  • 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.

  • 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.

  • 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.

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Directions apply to the region of specific pain or injury, reapply up to three times per daily, wash hands thoroughly in the event of contact, because activation takes about 1 hour, 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 sufferers: Apply three times daily for two weeks. Wait twenty minutes before washing arthritic hands. Thereafter use as needed.

  • SAFE HANDLING WARNING

    Other information
    Store at room temperature

  • INACTIVE INGREDIENT

    Inactive ingredients
    Carbomer, Chamomilla Recutita (Matricaria)
    Flower Extract, DMDM Hydantoin, Fragrance
    (Par fum), Imidazolidinyl Urea, Methylparaben,
    Polysorbate 20, Propyl Gallate,
    Propylene Glycol, Propylparaben,
    Triethanolamine, Water (Aqua)

  • QUESTIONS

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

  • DOSAGE & ADMINISTRATION

    apply to the region of specific pain or injury

  • PRINCIPAL DISPLAY PANEL

    image of package

  • INGREDIENTS AND APPEARANCE
    SCREAMIN HOT TOAST 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52099-8005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52099-8005-1141 g in 1 TUBE; Type 0: Not a Combination Product06/19/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/19/2012
    Labeler - Q.A. Laboratories (065361149)
    Registrant - Q.A. Laboratories (065361149)
    Establishment
    NameAddressID/FEIBusiness Operations
    Q.A. Laboratories065361149manufacture(52099-8005)
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