Label: DR BOB ARNOTS PAIN PEN- camphor (natural) liquid
- 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.
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- Active Ingredient
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprainsClose
For external use only.
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
- 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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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.
- 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, ZeodaryClose
- Other Information
Keep sealed in a dry environment at no more than 85°F / 29°C and avoid any direct sun exposureClose
- SPL UNCLASSIFIED SECTION
Larasan Pharmaceutical Corporation
401 East Las Olas Boulevard, Suite 1400
Ft. Lauderdale, FL 33301
- 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)