PAINFIX RELIEF (MENTHOL) GEL [PAINFIX LLC]

PAINFIX RELIEF (MENTHOL) GEL [PAINFIX LLC]
PDF | XML

NDC 72749-001-00
Set ID 4320db2b-69d0-421b-9890-eeb8c40318ec
Category HUMAN OTC DRUG LABEL
Packager PainFix LLC
Generic Name
Product Class
Product Number
Application Number PART348
  • Drug Facts

  • Active Ingredients

    Menthol 5%

    Purpose

    `Topical analgesic

  • Uses

    temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains

  • Warnings

    Avoid direct contact with eyes. For external use only.

    When using this product

    • use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions

    Adults and children above 12 years:

    • apply gel to affected area(s) and massage gently until thoroughly absorbed into skin
    • repeat up to 3 to 4 times per day, on an as needed basis
    • after applying, wash hands with soap and water

    Children 12 years and younger, ask a health professional

  • Other Information

    Store in a cool, dry place, away from direct sunlight.

  • Ingredients

    Aloe barbadensis extract, Angelica anomala extract, Caprylyl glycol (and) Phenethyl alcohol, Carbomer, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract,
    Curcuma zedoaria extract, Daemonops draco extract, Drynaria fortunei extract, Glycerin, Pistacia lentiscus extract, Propylene glycol, Rheum officinale extract, Scutellaria baicalenis extract, Water (Aqua)

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    PAINFIX RELIEF 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72749-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72749-001-001 in 1 BOX02/01/2019
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/01/2019
    Labeler - PainFix LLC (116908667)

Related Drugs