RxNorm Names

Review RxNorm Normal Forms

DR BOB ARNOTS PAIN (camphor (natural), menthol) patch
[Larasan Pharmaceutical Corporation]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4efe8bf3-b465-4497-840f-d0a95ba5a572

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active Ingredients

Camphor, 3%

Menthol, 2.52%

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 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.

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

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.

Other Information

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

Questions/Comments?

www.larasan.com/painpatch

Distributed By

Larasan Pharmaceutical Corporation

401 East Las Olas Blvd., Suite 1400

Ft. Lauderdale, FL 33301

754-300-5060

DrAPainPatch20130104

DR BOB ARNOTS PAIN
camphor (natural), menthol patch

Product Information
Product Type	HUMAN OTC DRUG	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
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)

Revised: 12/2012

Document Id: ed9aa9c1-43e7-4f6e-9b5e-1870016124e3

Set id: 4efe8bf3-b465-4497-840f-d0a95ba5a572

Version: 1

Effective Time: 20121228