DR BOB ARNOTS PAIN PEN- camphor (natural) liquid
Larasan Pharmaceutical Corporation

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.

----------

Active Ingredient

Camphor, 7.79%

Purpose

Topical analgesic

Uses

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

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.

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.

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

Other Information

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

Questions/Comments?

www.larasan.com/painpen

Distributed by:

Larasan Pharmaceutical Corporation

401 East Las Olas Boulevard, Suite 1400

Ft. Lauderdale, FL 33301

754-300-5060

DrAPainPen20130108

DR BOB ARNOTS PAIN PEN
camphor (natural) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54641-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	7.79 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ACONITUM KUSNEZOFFII ROOT (UNII: 3L29I4K8KX)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ASARUM HETEROTROPOIDES VAR. MANDSHURICUM ROOT (UNII: HK49KSK8L3)
DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
ALCOHOL (UNII: 3K9958V90M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
FORSYTHIA SUSPENSA FRUIT (UNII: P4793M1ES5)
FRANKINCENSE (UNII: R9XLF1R1WM)
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON (UNII: 24RS0A988O)
MYRRH (UNII: JC71GJ1F3L)
PAEONIA SUFFRUTICOSA ROOT BARK (UNII: BUG255FE7X)
PEPPERMINT OIL (UNII: AV092KU4JH)
PINELLIA TERNATA ROOT (UNII: G9AET085M5)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
RHUBARB (UNII: G280W4MW6E)
SAFFLOWER (UNII: 4VBL71TY4Y)
TANGERINE PEEL (UNII: JU3D414057)
TURMERIC (UNII: 856YO1Z64F)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ZANTHOXYLUM NITIDUM ROOT (UNII: L2CQZ81759)
ZEDOARY (UNII: 123C43G128)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54641-002-02	10 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/08/2013	02/05/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/08/2013	02/05/2017

Labeler - Larasan Pharmaceutical Corporation (078350375)

Name	Address	ID/FEI	Business Operations
Establishment
Dong-e E-jiao E-hua Medical Equipment Co Ltd		527813247	manufacture(54641-002)

Revised: 2/2017

Document Id: ef69811f-e273-4104-9eb8-7bee24af374b

Set id: fd119033-20d8-4037-90d9-b572a411cc5b

Version: 3

Effective Time: 20170205

Larasan Pharmaceutical Corporation