Label: DR BOB ARNOTS PAIN PEN- camphor (natural) liquid 

  • Label RSS
  • NDC Code(s): 54641-002-02
  • 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 01/13

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

  • Active Ingredient

    Camphor, 7.79%

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  • Purpose

    Topical analgesic

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  • Uses

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

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  • 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 if excessive irritation of the skin develops
    • Avoid contact with the eyes or 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 pregnancy 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.

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  • Directions

    • Adults and children 2 years of age and older: Apply to affected area as needed and when required. Remove the cap and move the pen in a circular motion. Replace cap when not in use.
    • Children under 2 years of age: consult a doctor.
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  • Inactive Ingredients

    Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. Mandshuricum Root, Drynaria Fortunei Root, Eleutherococcus Nodiflorus Root Bark, Ethyl Alcohol, Eucalyptus Oil, Frosythia Suspensa Fruit, Frankincense, Gardenia Jasminoides Fruit, Lavender Oil, Lemon, Myrrh, Paeonia Suffruticosa Root Bark, Peppermint Oil, Pinellia Ternata Root, Red Paeonia Lactiflora Root, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

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  • Other Information

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

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  • Questions/Comments?

    www.larasan.com/painpen

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Larasan Pharmaceutical Corporation

    401 East Las Olas Boulevard, Suite 1400

    Ft. Lauderdale, FL 33301

    754-300-5060

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  • INGREDIENTS AND APPEARANCE
    DR BOB ARNOTS PAIN PEN 
    camphor (natural) liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54641-002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 7.79 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ACONITUM KUSNEZOFFII ROOT  
    ANGELICA DAHURICA ROOT  
    ANGELICA SINENSIS ROOT  
    ASARUM HETEROTROPOIDES VAR. MANDSHURICUM ROOT  
    DRYNARIA FORTUNEI ROOT  
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK  
    ALCOHOL  
    EUCALYPTUS OIL  
    FORSYTHIA SUSPENSA FRUIT  
    FRANKINCENSE  
    GARDENIA JASMINOIDES FRUIT  
    LAVENDER OIL  
    LEMON  
    MYRRH  
    PAEONIA SUFFRUTICOSA ROOT BARK  
    PEPPERMINT OIL  
    PINELLIA TERNATA ROOT  
    PAEONIA LACTIFLORA ROOT  
    REHMANNIA GLUTINOSA ROOT  
    RHUBARB  
    SAFFLOWER  
    TANGERINE PEEL  
    TURMERIC  
    METHYL SALICYLATE  
    ZANTHOXYLUM NITIDUM ROOT  
    ZEDOARY  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54641-002-02 10 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 01/08/2013
    Labeler - Larasan Pharmaceutical Corporation (078350375)
    Establishment
    Name Address ID/FEI Business Operations
    Dong-e E-jiao E-hua Medical Equipment Co Ltd 527813247 manufacture(54641-002)
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