PAIN RELIEF PATCH- camphor, menthol, methyl salicylate patch

Pain Relief Patch by

Drug Labeling and Warnings

Pain Relief 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

Pain Relief Patch

ACTIVE INGREDIENT

Camphor 3.1%

Menthol 6.0%

Methyl Salicylate 10.0%

PURPOSE

For the temporary minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
sprains

INDICATIONS & USAGE

For the temporary minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
sprains

WARNINGS

For external use only

if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

DO NOT USE

on wounds or damaged skin

with a heating pad

at the same time as other topical analgesics

if you are allergic to any ingredients of this product

WHEN USING

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

STOP USE

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
if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over:

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

STORAGE AND HANDLING

store in a clean, dry place outside of direct sunlight

protect from excessive moisture

INACTIVE INGREDIENT

hydrogenated poly

Pentaerythrityl tetra-di-t-butyl

hydroxyhydrocinnamate

petroleum

styrene/isoprene copolymer

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF PATCH 
camphor, menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	3.1 mg  in 100
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 mg  in 100
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 mg  in 100

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYISOBUTENE 8 (UNII: 7YR4ZFS62E)
NAPHTHA (UNII: O3L624621X)
ETHYL P-HYDROXYHYDROCINNAMATE (UNII: 8R568DFF4T)
STYRENE (UNII: 44LJ2U959V)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-801-02	15 in 1 BOX	07/26/2023
1	NDC: 81484-801-01	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	07/26/2023

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Miao De Tang Pharmaceutical Co., Ltd.		405744102	manufacture(81484-801)