Label: AVEDANA PAIN RELIEF- menthol spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 2024

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  • Active ingredients

    Active ingredients                                                                         Purpose
    Natural Menthol USP 9%....................................................Topical Analgesic

  • Purpose

    Active ingredients                                                                       Purpose
    Natural Menthol USP 9%....................................................Topical Analgesic

  • Directions

    Directions: Spray to completely cover painful area.  Get extra relief by using after warm shower or bath.  Reapply as needed.

  • Warnings

    For external use only.

  • Flammable

    Keep away from excessive heat or open flames.

  • Ask a doctor before using if you

    Ask a doctor before using if you: have sensitive skin, are pregnant or are breast feeding.

  • When using this product:

    When using this product: 

    -Avoid contact with eyes and mucous membranes.

    -Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.

  • Stop use and ask a doctor if:

    Stop use and ask a doctor if: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

  • Keep out of reach of children:

    Keep out of reach of children: If ingested, seek medical help and contact poison control center immediately.

  • Other information

    Store in a cool, dry place with spray cap screwed tightly.

  • Inactive Ingredients:

    Inactive Ingredients: Arnica montana, Boswellia serrata Extract, Camphor USP, Coconut Oil, Eucalyptus globulus Leaf Oil, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Lavender Oil, Methyl salicylate, Peppermint Oil, Propylene Glycol USP, and Purified Water

  • Directions

    Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.

  • Avedana ® Pain Relieving Spray

    Made with All - Natural Botanical Ingrdeints.

    Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA PAIN RELIEF 
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-510
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-510-04118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/29/2014
    Labeler - Unipack LLC (009248480)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-510)
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