Label: ANALGESIC- menthol spray 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 01/11

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

  • SPL UNCLASSIFIED SECTION

    Premiere Enterprises, Inc.

    Pain Spray

    Drug Facts

    Close
  • Active Ingredients

    USP Menthol 7%

    Close
  • Purpose

    Topical Analgesic

    Close
  • Uses:

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

    Close
  • 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.
    Close
  • 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.

    Close
  • Other Information:

    Store at room temperature.

    Close
  • Inactive Ingredients:

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

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

    Manufactured for:

    PREMIERE ENTERPRISES, INC.

    Los Angeles, CA 90034

    Close
  • PRINCIPAL DISPLAY PANEL

    NDC 32472-102-03

    PREMIERE'S

    Pain Spray™

    Roll-On

    A miracle in every bottle!

    TEMPORARY RELIEF OF

    MINOR ACHES & PAINS

    ARTHRITIS ● BACKACHE

    STIFF JOINTS ● SORE MUSCLES

    SPRAINS ● BRUISES

    NATURAL MENTHOL ● HERBAL FORMULA

    Net 3 fluid oz./88 ml.

    PRINCIPAL DISPLAY PANEL
    Close
  • INGREDIENTS AND APPEARANCE
    ANALGESIC 
    menthol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:32472-102
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    menthol (menthol) menthol 700 mL  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    water  
    isopropyl alcohol  
    glycerin  
    eucalyptus oil  
    methyl salicylate  
    peppermint oil  
    coconut oil  
    xanthan gum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:32472-102-03 0.088 L in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/12/2011
    Labeler - Premiere Enterprises (556225498)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE
    Close