Label: SIGFORM HERBAL MUSCLE MIST- menthol and camphor solution

  • 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 April 1, 2015

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  • Active ingredient

    Menthol USP 6%
    Camphor 2%

  • Purpose

    Pain Relief

  • Other ingredients

    Isopropyl Alcohol, MSM (Methylsulfonylmethane), Eucalytus Globulus Leaf Oil, Sweet Birch Oil, Peppermint Oil, Clove Bud Oil, Arnica Oil.

  • Uses

    For the temporary relief of minor aches and pains at muscles and joints associated with sore muscles, strains, joint discomfort, and arthritis.

  • Warnings

    For external use only. Avoid contact with eyes. Do not apply to wounds or damaged skin. If pregnant or breast feeding ask a health care professional before use. Flammable: Keep away from fire or flame.

  • Keep Out of Reach of Children

    If swallowed get medical help or cantact a poison control center.

  • Directions

    Adults and children over 12 years. Spray onto neck and shoulders to help relieve tension and stress. Rub into temples to help with headaches. Spray onto chest to relieve cold and flu. Apply prior to a workout or sports activity.

  • Manufactured in a FDA facility Exclusively for

    Sigform LLC
    Tempe, Arizona

  • Package/Label Principal Display Panel

    Sigform
    SCIENCE & HEALTH

    NATURAL PAIN RELIEF

    HERBAL
    MUSCLE
    MIST

    naturally balanced

    THE NATURAL SOLUTION THAT WORKS!

    4oz (120ml) Spray

    Naturally Reduces
    Inflammation | Arthritis | Back Pain
    Muscle Aches | Join Pain | Restores Blood Flow

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    SIGFORM HERBAL MUSCLE MIST 
    menthol and camphor solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69257-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CLOVE OIL (UNII: 578389D6D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69257-210-20120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/15/2015
    Labeler - Signature Formulations LLC (079126258)
    Registrant - Signature Formulations LLC (079126258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Signature Formulations LLC079126258MANUFACTURE(69257-210)
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