Label: PROFOOT PLANTAR RELIEF STRIPS (camphor- natural, menthol, methyl salicylate patch

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

Drug Label Information

Updated October 19, 2023

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  • Drug Facts

  • Active ingredients

    Camphor 1.2%

    Menthol 5.7%

    Methyl salicylate 6.3%

    Purpose

    Topical Analgesic

  • Uses

    For temporary relief of minor aches & pains of muscles & joints associated with: • arthritis • strains • bruises • sprains

  • Warnings

    For external use only

    Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    Do not use

    • on wounds or damaged skin • with a heating pad • if you are allergic to any ingredients of this product

    When using this product

    • use only as directed • avoid contact with the eyes, mucocus membranes or rashes • do not bandage tightly

    Stop use and ask a doctor if

    • rash, itching or excessive skin irritation develops • condtions worsen • symtomps persist for more than 7 days • symptoms clean up and occur again within a few days

    If pregnant or reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area • hold patch wide end up to make a "I" shape • only peel off film on wide end first, stopping halfway • apply patch so that wings wrap around arch •remove remaing film & pull back to wrap around heel • apply to affected area not more than 3-4 times daily • remove patch from skin after at most 8 hours

    Children under 12 years of age:consult a doctor 

  • Other information

    • avoid storing in direct sunlight • protect product from excessive moisture

  • Inactive ingredients

    hydrogenated poly, pentaerythrityl tetra-di-t-butyl Hydroxyhydrocinnamate, white mineral oil, styrene/Isoprene copolymer

  • Questions or comments?

    Email cservice@profoot.co

  • Package Labeling:

    Profoot labelLabel

  • INGREDIENTS AND APPEARANCE
    PROFOOT PLANTAR RELIEF STRIPS 
    camphor (natural), menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)12 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL57 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE63 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29784-602-011 in 1 BOX10/18/2023
    14 in 1 POUCH
    11.03 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/18/2023
    Labeler - Profoot Inc. (107570900)
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