CAPSAICIN HEAT- capsaicin patch

Capsaicin Heat by

Drug Labeling and Warnings

Capsaicin Heat by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Zhejiang Dingtai Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Capsicum Extract Capsaicin 0.025%

PURPOSE

Purpose

Topical Analgesic

INDICATIONS & USAGE

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

• Simple Backache
• Arthritis
• Strains
• Bruises
• Sprains

WARNINGS

Warnings

External use only.

DO NOT USE

Do not use

• on wounds or damaged skin
• with a heating pad
• with, or at the same times as other external analgesic
• if you are allergic to any ingredients of this product

WHEN USING

When using this product

• do not use otherwise than as directed.
• avoid contact with the eyes, mucous membranes or rashes
• do not bandage tightly
• discontinue use at least 1 hour before a bath or shower
• do not use immediately after a bath or shower

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

KEEP OUT OF REACH OF CHILDREN

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

DOSAGE & ADMINISTRATION

Directions

Adults and Children 12 years of age and over:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area not more than 3 to 4 times daily
• Remove patch from skin after at most 8 hours of application

Children under 12 years of age: Consult a doctor.

SPL UNCLASSIFIED SECTION

Other information

• Avoid storing product in direct sunlight
• Protect product from excessive moisture

INACTIVE INGREDIENT

Inactive Ingredients

lanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Capsaicin Heat Patch

INGREDIENTS AND APPEARANCE

CAPSAICIN HEAT 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
METHYL SALICYLATE (UNII: LAV5U5022Y)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)
PEPPERMINT OIL (UNII: AV092KU4JH)
PETROLATUM (UNII: 4T6H12BN9U)
ROSIN (UNII: 88S87KL877)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-040-41	1 in 1 BOX	03/07/2019
1	NDC: 52000-040-40	2 in 1 POUCH
1		3.28 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/07/2019

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Dingtai Pharmaceutical Co., Ltd		420598724	manufacture(52000-040)