MUSCLE MIST (MENTHOL, CAMPHOR) SOLUTION [SIGNATURE FORMULATIONS LLC]

MUSCLE MIST (MENTHOL, CAMPHOR) SOLUTION [SIGNATURE FORMULATIONS LLC]
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NDC 69257-110-10
Set ID e611c0fa-fda6-474b-af93-af4915cb702b
Category HUMAN OTC DRUG LABEL
Packager Signature Formulations LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Active ingredient

    Menthol USP 6%
    Camphor 2%

  • Purpose

    Pain Relief

  • Other ingredients

    The Isopropyl Alcohol, Camphor Powder, Eucalyptus, Globulus Leaf Oil, Sweet Birch Oil, Peppermint Oil, Clove Bud 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. Keep out of reach of children. If swallowed get medical help or contact a poison control center. Flammable: Keep away from fire or flame.

  • Keep Out of Reach of Children

  • 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 help relieve cold and flu. Apply prior to a workout or sports activity

    Manufactured for:

    Holistic Earth Remedies
    Phoenix, Arizona 602.300.3691
    holisticearthremedies.com

  • Package/Label Principal Display Panel

    HERBAL
    MUSCLE MIST

    THE NATURAL SOLUTION THAT WORKS!

    Help reduce…

    Inflammation ●
    Arthritis ●
    Back Pain ●
    Muscle Aches ●
    Joint Pain ●
    Restores Blood Flow ●

    Holistic Earth Remedies

    4 FL OZ (120ml)

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    MUSCLE MIST 
    menthol, camphor solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69257-110
    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)  
    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:69257-110-10120 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 finalpart34810/20/2014
    Labeler - Signature Formulations LLC (079126258)
    Registrant - Signature Formulations LLC (079126258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Signature Formulations LLC079126258MANUFACTURE(69257-110)

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