CAPSICUM PATCH- camphor,capsicum extract as capsaicin, menthol patch

Capsicum Patch by

Drug Labeling and Warnings

Capsicum Patch by is a Otc medication manufactured, distributed, or labeled by Anhui Miao De Tang Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

CAPSICUM PATCH

ACTIVE INGREDIENT

Camphor 9.6%

Capsicum extract as Capsaicin 0.25%

Menthol 7.8%

PURPOSE

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

· arthritis

· simple backache

· strains

· bruises

INDICATIONS & USAGE

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

arthritis

simple backache

strains

bruises

TOPICAL ANALGESIC

WARNINGS

For external use only

When using this product

avoid contact with the eyes
do not apply to wounds or damaged skin
do not bandage tightly
use only as directed
avoid contact with the eyes, mucous membranes, or rashes

DO NOT 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

WHEN USING

lf 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 right away.

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

Keep out of reach of children.

STORAGE AND HANDLING

avoid storing products in direct sunlight.

protect products from excessive moisture.

INACTIVE INGREDIENT

lanolin, lithopone, paraffin, resin, rosin, vaseline

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older:
clean and dry the affected area.

remove the patch from the film.

apply to affected area not more than 3 to 4 times daily for 7 days

remove patch from the skin after at most 8-hour application

Children under 12 years of age:

consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAPSICUM PATCH 
camphor,capsicum extract as capsaicin, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.8 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	9.6 g

Inactive Ingredients
Ingredient Name	Strength
TERPENE RESIN (UNII: GR35AH6YDN)
ROSIN (UNII: 88S87KL877)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
LANOLIN (UNII: 7EV65EAW6H)
LITHOPONE (UNII: BU2HVV8RW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-701-02	20 in 1 BOX	06/21/2023
1	NDC: 81484-701-01	1 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/21/2023

Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Miao De Tang Pharmaceutical Co., Ltd.		405744102	manufacture(81484-701)