Arth Rx Topical Analgesic

Arth Rx Topical Analgesic
SPL v5
SPL
SPL Set ID a7b3b9b4-b1c4-4e51-8e3a-c84f64c75609
Route
TOPICAL
Published
Effective Date 2011-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacin (0.5 g) Capsaicin (0.025 g)
Inactive Ingredients
Isopropyl Alcohol Water Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) C13-14 Isoparaffin Polysorbate 80 Laureth-7 Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-02-12

Description

Active Ingredients                  Purpose     Methyl nicotinate 0.5%          External Analgesic Capsaicin 0.025 %                External Analgesic


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

When Using This Product

- Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly





Dosage and Administration

Directions - Adults apply to affected area no more than 3-4 times daily - Children under 18 consult a physician - Apply to small area of the skin as test for sensitivity at least 60 minutes prior to applying to wide area.







Description

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual usually decreasing or disappearing after continued use. Please read package insert prior to use. ..........  may be removed from the test area by wiping or olive oil.

Distributed by: HCD sales, Inc, Tampa, FL 33549 www.hcdsales.com







Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

Section 50566-9

Stop use and ask doctor if

-  Condition worsens - Excessive irritation of the skin develops - Pain persists for more than 7 days - Symptoms clear up and occur again within a few days







Section 51727-6

Inactive Ingredients

Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.

Section 51945-4

arth.Rx  TOPICAL ANALGESIC  ARTHRITIS PAIN RELIEF  PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)

Section 53413-1

Questions or comments

Toll free 1-800-729-8446

Section 55105-1

Uses: Temporarily relieves minor aches and pains of muscles and joints due to:

- Arthritis - Strains - Sprains

Section 55106-9

Active Ingredients                  Purpose     Methyl nicotinate 0.5%          External Analgesic Capsaicin 0.025 %                External Analgesic






Structured Label Content

Indications and Usage (34067-9)

When Using This Product

- Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly





Dosage and Administration (34068-7)

Directions - Adults apply to affected area no more than 3-4 times daily - Children under 18 consult a physician - Apply to small area of the skin as test for sensitivity at least 60 minutes prior to applying to wide area.







Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Description (34089-3)

Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual usually decreasing or disappearing after continued use. Please read package insert prior to use. ..........  may be removed from the test area by wiping or olive oil.

Distributed by: HCD sales, Inc, Tampa, FL 33549 www.hcdsales.com







Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

Section 50566-9 (50566-9)

Stop use and ask doctor if

-  Condition worsens - Excessive irritation of the skin develops - Pain persists for more than 7 days - Symptoms clear up and occur again within a few days







Section 51727-6 (51727-6)

Inactive Ingredients

Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.

Section 51945-4 (51945-4)

arth.Rx  TOPICAL ANALGESIC  ARTHRITIS PAIN RELIEF  PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)

Section 53413-1 (53413-1)

Questions or comments

Toll free 1-800-729-8446

Section 55105-1 (55105-1)

Uses: Temporarily relieves minor aches and pains of muscles and joints due to:

- Arthritis - Strains - Sprains

Section 55106-9 (55106-9)

Active Ingredients                  Purpose     Methyl nicotinate 0.5%          External Analgesic Capsaicin 0.025 %                External Analgesic






Advanced Ingredient Data


Raw Label Data

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