Label: ARTH RX TOPICAL ANALGESIC- methyl nicotinate, capsaicin lotion
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- NDC Code(s): 76069-100-03
- Packager: HCD Sales
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 17, 2017
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
Active Ingredients Purpose
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Methyl nicotinate 0.5% External Analgesic
Capsaicin 0.025 % External Analgesic
- PURPOSE
Uses: Temporarily relieves minor aches and pains of muscles and joints due to:
- Arthritis - Strains - Sprains
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- WARNINGS
- INDICATIONS & USAGE
When Using This Product
- Avoid contact with eyes
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- Do not apply to wounds or damaged skin
- Do not bandage tightly
- STOP USE
Stop use and ask doctor if
- Condition worsens
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- Excessive irritation of the skin develops
- Pain persists for more than 7 days
- Symptoms clear up and occur again within a few days
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.
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- DOSAGE & ADMINISTRATION
Directions
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- 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.
- INACTIVE INGREDIENT
Inactive Ingredients
Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.
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- QUESTIONS
- 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:
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HCD sales, Inc,
Tampa, FL 33549
www.hcdsales.com
- PRINCIPAL DISPLAY PANEL
arth.Rx TOPICAL ANALGESIC ARTHRITIS PAIN RELIEF PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)
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- INGREDIENTS AND APPEARANCE
ARTH RX TOPICAL ANALGESIC
methyl nicotinate, capsaicin lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76069-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL NICOTINATE (UNII: 7B1AVU9DJN) (NIACIN - UNII:2679MF687A) METHYL NICOTINATE 0.5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) POLYSORBATE 80 (UNII: 6OZP39ZG8H) LAURETH-7 (UNII: Z95S6G8201) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76069-100-03 85 g in 1 BOTTLE; Type 0: Not a Combination Product 02/05/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/12/2011 CloseLabeler - HCD Sales (137317314)