Label: HEALTHWISE 3X MEDICATED PAIN RELIEF PATCH 120 BULK- camphor,menthol, methyl salicylate patch

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

Drug Label Information

Updated April 30, 2024

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  • Active ingredients

    Camphor 3.1%

    Menthol 6%

    Methyl Salicylate 10%

  • Purposes

    Topical analgesic

    Topical analgesic

    Topical analgesic

  • Use

    For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, muscle strains, muscle sprains, and bruises.

  • Warnings

    For external use only

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

    Do not use

    ■More than one patch on your body at a time

    ■ 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 and avoid contact with eyes, mucous membranes or rashes

    ■ Do not bandage tightly

    ■ Do not use at the same time as other topical analgesics

    ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

    Stop use and ask a doctor if

    ■ Rash, itching, or excessive skin irritation develops

    ■ Condition worsens

    ■ Symptoms last more than 7 days or clear up and occur again within a few days.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children and pets.

    If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

  • Directions

    Adults and children 12 years of age and over:

    ■ Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area.Do not use more than one patch in a 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

    Children under 12 years of age: ■ Consult a physician.

  • Other information

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture

  • Inactive ingredients

    hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEALTHWISE 3X MEDICATED PAIN RELIEF PATCH 120 BULK 
    camphor,menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL6 g
    Inactive Ingredients
    Ingredient NameStrength
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71101-032-12120 in 1 BOX04/01/2024
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2024
    Labeler - Veridian Healthcare (830437997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-032)
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