Label: PREMIERES PAIN- menthol spray

  • 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 12, 2011

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  • SPL UNCLASSIFIED SECTION

    Premiere Enterprises, Inc.

    Pain Spray

    Drug Facts

  • Active Ingredients

    USP Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses:

    Temporary relief of minor aches and pains of muscles and joints.

  • Warnings:

    • For external use only
    • Flammable. Keep away from flame.

    • Keep out of reach of children- if swallowed get medical help or contact a poison center right away.
    • Avoid contact with eyes
    • Do not apply to open wounds or damaged skin
    • Do not bandage tightly
    • Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
  • Directions:

    For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Get extra relief by using after warm shower or bath. Will not stain clothing. For children under 2 years of age, consult a Doctor.

  • Other Information:

    Store at room temperature.

  • Inactive Ingredients:

    Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum

  • 1-800-576-7616 Amazing-Solutions.com

    Manufactured for:

    PREMIERE ENTERPRISES, INC.

    Los Angeles, CA 90034

  • Principal Display Panel - Bottle Label

    NDC# 32472-102-03

    PREMIERE'S
    PAIN SPRAY
    ROLL ON    ™

    A Miracle in Every Bottle¡

    Temporary Relief
    Of Minor Aches
    & Pains

    MINOR SPORTS INJURIES

    BACKACHES SORE MUSCLES

    SPRAINS ARTHRITIS

    MUSCLE CRAMPS

    Net 3 fluid oz./88ml.

    Natural Menthol • Herbal Formula

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    PREMIERES PAIN 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:32472-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isopropyl alcohol (UNII: ND2M416302)  
    glycerin (UNII: PDC6A3C0OX)  
    eucalyptus oil (UNII: 2R04ONI662)  
    methyl salicylate (UNII: LAV5U5022Y)  
    peppermint oil (UNII: AV092KU4JH)  
    coconut oil (UNII: Q9L0O73W7L)  
    xanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:32472-102-0388 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/12/2011
    Labeler - Premiere Enterprises (556225498)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(32472-102)
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