DR 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.

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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 ARNOTS PAIN PEN
camphor (natural) liquid

Product Information
Product Type	HUMAN OTC DRUG	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 g

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

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:54641-002-02	0.779 g in 1 BOTTLE, WITH APPLICATOR	None

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	Operations
Dong-e E-jiao E-hua Medical Equipment Co Ltd		527813247	manufacture

Revised: 01/2013 Larasan Pharmaceutical Corporation