Label: DR BOB ARNOTS PAIN- camphor (natural) and menthol patch

  • NDC Code(s): 54641-001-01
  • Packager: Larasan Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Active Ingredients

    Camphor, 3%

    Menthol, 2.52%

    Close
  • Purpose

    Topical analgesic

    Close
  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

    Close
  • Warnings

    For external use only

    Do not

    Apply to open wounds, or damaged, broken, or irritated skin

    Stop Use and Ask a Doctor If

    Condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Caution

    • Discontinue use is excessive irritation of the skin develops
    • Avoid contact with the eyes and mucous membranes
    • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately

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

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

    Close
  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children over 12 years:

    • Remove plastic backing from patch and discard
    • Apply one patch to affected area
    • Repeat as necessary, but no more than 3 per day
    • Patch should be comfortable but not tight
    Close
  • Inactive Ingredients

    Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide.

    Close
  • Other Information

    Keep sealed in a dry environment at no more than 85 deg F / 29 deg C and avoid any direct sun exposure

    Close
  • Questions/Comments?

    www.larasan.com/painpatch

    Close
  • Distributed By

    Larasan Pharmaceutical Corporation

    401 East Las Olas Blvd., Suite 1400

    Ft. Lauderdale, FL 33301

    754-300-5060

    Close
  • INGREDIENTS AND APPEARANCE
    DR BOB ARNOTS PAIN 
    camphor (natural), menthol patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54641-001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 3 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 2.52 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    ANGELICA DAHURICA ROOT  
    ATRACTYLODES LANCEA ROOT  
    BORNEOL  
    ANGELICA SINENSIS ROOT  
    CHONDROITIN SULFATE (PORCINE)  
    GINGER  
    KAEMPFERIA GALANGA ROOT  
    ACONITUM KUSNEZOFFII ROOT  
    LEMON  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT  
    MINERAL OIL  
    OXACYCLOHEPTADEC-8-EN-2-ONE, (8Z)-  
    PETROLATUM  
    ACONITUM CARMICHAELII ROOT  
    ROSIN  
    SILICON  
    STAR ANISE  
    METHYL SALICYLATE  
    ZINC OXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54641-001-01 7 in 1 PACKAGE
    1 1.56 g in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 12/28/2012
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    Name Address ID/FEI Business Operations
    Dong-e E-jiao E-hua Medical Equipment Co Ltd 527813247 manufacture(54641-001)
    Close