HOT PAIN RELIEF- capsaicin patch patch

HOT PAIN RELIEF by

Drug Labeling and Warnings

HOT PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by MCURE HEALTH SOLUTIONS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

PURPOSE

Uses

For temporary relief associated with:

• Arthritis
• Backaches
• Bruises
• Sprains & Strains
• Joint & Muscle Pain

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use:

• On the face or rashes
• With a heating pad
• On wounds or damaged skin
• if you are allergic to any ingredients of this product

WHEN USING

When using this product:

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes

STOP USE

Stop use and ask a doctor if:

• Rash, itching or excessive skin irritation develops
• Conditions worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact a Poision Control Center right away.

INDICATIONS & USAGE

Directions

Adults and Children 12 years of age and over:

Clean and dry affected area.
Peel off protective film and apply patch once or twice a day.
Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.

Children Under 12 Years of Age: Consult a physician.

INACTIVE INGREDIENT

Inactive ingredients

Belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyster resin, zinc oxide

DOSAGE & ADMINISTRATION

Distributed by:

MCURE HEALTH SOLUTIONS INC.

20819 Currier Rd #200

City of Industry, CA 91789

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT PAIN RELIEF 
capsaicin patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	1.2 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
BELLADONNA LEAF (UNII: 6GZW20TIOI)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIPHENHYDRAMINE (UNII: 8GTS82S83M)
LANOLIN (UNII: 7EV65EAW6H)
PEPPERMINT OIL (UNII: AV092KU4JH)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
ZINC OXIDE (UNII: SOI2LOH54Z)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Product Characteristics
Color		Score
Shape	RECTANGLE (13cm*18cm)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-002-25	4800 mg in 1 PATCH; Type 0: Not a Combination Product	06/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/27/2017

Labeler - MCURE HEALTH SOLUTIONS INC. (053034873)

Registrant - MCURE HEALTH SOLUTIONS INC. (053034873)