Label: ARTH ARREST - methyl nicotinate and capsaicin cream
- NDC Code(s): 76018-100-03
- Packager: Key 2 Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
Methyl Nicotinate 0.5%
Capsaicin 0.025 %
For the temporary relief of minor aches and pains of muscles and joints.
FOR EXTERNAL USE ONLYClose
Warnings: Use only as directed, Avoid contact with eyes. Do not apply to wounds or damaged skin. Do not bandage tightly. If condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Please see outer box for additional warnings prior to use.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
If swallowed get medical help or contact a Poison Control Center immediately.
- DOSAGE & ADMINISTRATION
Directions: Adults and children 2 years of age and older. Apply to affected area no more than 3-4 times daily. Children under 2 years of age consult a physician.Close
- INDICATIONS & USAGE
How to apply: Apply to a small area of the skin as a test for sensitivity at least 60 minutes prior to applying to a wide area.Close
- INACTIVE INGREDIENT
Isopropyl Alcohol, Deionized Water, Neurocaine:(Lidocaine HCl, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Aloe Barbadensis Leaf (Aloe Vera) Gel, Arnica Montana Flower Extract, Ruta Graveolens (Rue) Extract, Chamomilla Recutita (Chamomile) Extract, Boswella Serrata Extract, Polysorbate-80, Fragrance).Close
Questions or comments
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- PRINCIPAL DISPLAY PANEL
Penetrating Pain Relief
Double Action Formula
Net Wt. 3 oz (85gm)Close
- INGREDIENTS AND APPEARANCE
methyl nicotinate, capsaicin cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76018-100 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL NICOTINATE (NIACIN) METHYL NICOTINATE 0.5 g in 100 g CAPSAICIN (CAPSAICIN) CAPSAICIN 0.025 g in 100 g Inactive Ingredients Ingredient Name Strength ISOPROPYL ALCOHOL WATER LIDOCAINE HYDROCHLORIDE POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) C13-14 ISOPARAFFIN LAURETH-7 ALOE VERA LEAF ARNICA MONTANA FLOWER CHAMOMILE POLYSORBATE 80 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76018-100-03 85 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 02/11/2011 Labeler - Key 2 Health, Inc. (126011142) Establishment Name Address ID/FEI Business Operations Pure Source Inc. 969241041 manufacture