Other
Pain Relief Patch
Pain Relief Patch
FDA Label NDC 81484-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Miao De Tang Pharmaceutical Co., Ltd. for the product Pain Relief Patch (NDC 81484-801). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Camphor 3.1%
Menthol 6.0%
Methyl Salicylate 10.0%
Otc - 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.
Otc - 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
Otc - When Using
use only as directed
avoid contact with the eyes, mucous membranes, or rashes
do not bandage tightly
Otc - 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
Otc - 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
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