Label: PAINFIX RELIEF- menthol gel

  • NDC Code(s): 72749-001-00, 72749-001-03
  • Packager: PainFix LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredients

    Menthol 5%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves aches and pains of joints and muscles associated with • backache • arthritis • 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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 Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Bambusa Vulgaris (Mastic) Sap Extract, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Cinnamomum Cassia Oil, Citrus Aurantium Dulcis (Orange) Extract, Commiphora Myrrha (Myrrh) Extract, Curcuma Longa (Turmeric) Extract, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Ilex Paraguariensis (Yerba Mate) Extract, Magnesium Sulfate, MethylSulfonylmethane (MSM), Polysorbate-20, Propylene Glycol, Rheum Palmatum (Rhubarb) Extract, Scutellaria Baicalensis (Skullcap) Extract, Sesamum Indicum (Sesame) Oil, Sodium Hydroxide, Sorbic Acid, Xanthan Gum, Zingiber Officinale (Ginger) Extract

  • SPL UNCLASSIFIED SECTION

    YOU GOT THIS

    Plant-Based

    www.painfixbody.com

    Made in USA

    Manufactured for:
    PainFix LLC
    Brooklyn, NY 11201

  • Packaging

    PainFix-1

  • 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, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BAMBUSA VULGARIS SAP (UNII: 26W4035XBO)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    MYRRH (UNII: JC71GJ1F3L)  
    TURMERIC (UNII: 856YO1Z64F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    RHUBARB (UNII: G280W4MW6E)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBIC ACID (UNII: X045WJ989B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72749-001-001 in 1 BOX02/01/201911/30/2022
    160 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72749-001-0357 g in 1 BOTTLE; Type 0: Not a Combination Product12/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2019
    Labeler - PainFix LLC (116908667)