Label: SIGFORM HERBAL MUSCLE- menthol and camphor gel

  • 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 2, 2015

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  • Active ingredient

    Menthol USP 6%
    Camphor 2%

  • Purpose

    Pain Relief

  • Other ingredients

    Purified Signature Water™, Methylsufonylmethane, Lubragel Np, Menthol crystals, Eucaliptus oil, Camphor powder, Peppermint oil, Clove Bud oil, Phenoxyethanol, Carbopol ultrez 10, Sweet Birch oil, Sodium bicarbonate, Potassium Sorbate.

  • Uses

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

  • Warnings

    Discontinue use if irritation or red skin develops, and consult a physician. Application is intended for external cosmetic use only. Consult a health care professional before using this or any product during pregnancy or while breastfeeding. Do not use around the eye area. Do not use if tamper-evident seal is broken or missing. Store in cool dry place.

    These statements have not been evaluated by the food and drug administration. This product is not intended to treat, cure or prevent any disease.

  • Keep Out of Reach of Children

  • Directions

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

  • Manufactured in a FDA registered facility by

    Signature Formulations LLC.
    Phoenix, AZ

  • Package/Label Principal Display Panel

    Sigform
    SCIENCE & HEALTH

    NATURALLY
    PRESERVED
    PARABEN FREE

    HERBAL
    MUSCLE
    GEL

    Help Reduce…
    Inflammation
    Arthritis
    Back Pain
    Muscle Aches
    Joint Pain

    naturally balanced

    THE NATURAL
    SOLUTION THAT WORKS!

    FORMULATED
    WITH CARE

    3.1 oz (90g)
    approx 80 pumps

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    SIGFORM HERBAL MUSCLE 
    menthol and camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69257-212
    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
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CLOVE OIL (UNII: 578389D6D0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69257-212-2290 mL in 1 BOTTLE, PUMP; 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(69257-212)
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