CAPSAICIN ARTHRITIS PAIN RELIEF CREAM- capsaicin cream
McCure Health Solutions Inc.

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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Capsaicin Arthritis Pain Relief Cream

Drug Facts

Active ingredient

Capsaicin 0.1%

Purpose

Topical analgesic

Uses

for the temporary relief of minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises

Warnings

For external use only

When using this product

• use only as directed • do not bandage tightly • do not use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds, damaged, broken or irritated skin • a slight burning sensation may occur upon application but generally disappears in several days • if severe burning occurs, discontinue use • do not expose the treated area to heat or direct sunlight • do not use if allergic to capsicum or chili peppers

Stop use and ask a doctor if

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 18 years: • apply generously to affected area not more than 3 to 4 times daily • massage into painful area until thoroughly absorted • wash hands with soap and water after use • close cap tightly after use Children 18 years or younger: Ask a doctor

Other information

• store at room temperature

Inactive ingredients

BENZYL ALCOHOL, CETYL ALCOHOL, ISOPROPYL MYRISTATE, POLYOXYL 40 STEARATE, PURIFIED WATER, SORBITAN MONOSTEARATE, SORBITOL SOLUTION, WHITE PETROLATUM

Product Label

CAPSAICIN

CAPSAICIN ARTHRITIS PAIN RELIEF CREAM
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52486-011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)

#	Item Code	Package Description
Packaging
1	NDC:52486-011-42	1 in 1 CARTON
1		42.5 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/27/2015

Labeler - McCure Health Solutions Inc. (053034873)

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Dedi Medical Device Co., Ltd..		421353662	manufacture(52486-011)

Revised: 4/2015

Document Id: 631f0f9a-d213-44cb-83b7-5bd6f277cd73

Set id: 7c31736c-edaa-4390-a2fb-eab2fd495f7d

Version: 2

Effective Time: 20150401

McCure Health Solutions Inc.