Label: LARGE PAIN RELIEVING- camphor menthol methyl salicytate patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2020

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

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Camphor 3.1% Topical Analgesic
    Menthol 6.0% Topical Analgesic
    Methyl Salicylate 10.0% Topical Analgesic

  • INACTIVE INGREDIENThydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

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

  • WARNINGS

    For External Use Only

    Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years:

    Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

    Do not use for more than 8 hours.

    Discard patch after use.

    Reseal pouch after opening.

    Children under 12 years of age, consult a physician.

  • If pregnant or breastfeeding

    ask a health professional before use.

  • PURPOSE

    Topical Analgesic

  • When using this product:

    ■ Use only as directed ■ 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.

  • Do not use

    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients in this product.
  • Stop use and consult a doctor

    • If rash, itching or excessive skin irritation develops
    • If condition worsens
    • If symptoms last more than 7 days or clear up and occur again in a few days.
  • Storage and Care

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

  • Pain Relieving Path

    DIST. BY
    Walgreens Co.
    200 Wilmot Rd
    . Deerfield, IL 60015
    www.walgreens.com

    TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

    Label Image
  • INGREDIENTS AND APPEARANCE
    LARGE PAIN RELIEVING 
    camphor menthol methyl salicytate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6.0 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
    STYRENE (UNII: 44LJ2U959V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9904-066 in 1 BOX01/01/2020
    19 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2020
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(0363-9904)