Otc - Active Ingredient
Active Ingredient ( in each patch) Purpose
Menthol 0.2 percent Analgesic
Pain Relieving Patch
FDA Label NDC 50309-777
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heilongjiang Huashen Science & Technology Development Co Ltd for the product Pain Relieving Patch (NDC 50309-777). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, dosage & administration, description, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses:For the temporary relief of pain.
Warnings
Warnings:
For external use only. Avoid contact with the eyes.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again
within a few days, discontinue use of this product and consult a doctor.
Otc - Do Not Use
Do not use
- otherwise than as directed
- in the eyes or ears
- if you are pregnant
- if you have skin allergy or damage to skin
Otc - Stop Use
Stop use and ask a doctor if
- redness is present
- excessive irritation of the skin develops
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions:
Adults and children 2 years of age and older: Remove patch from package. Apply to affected area not more than 3-4 times daily. Leave bandage
on for no more than 48 hours.
Children under 2 years of age: Consult a doctor.
Description
Manufactured by:
Heilongjiang Huashen Science and Technology
Development Co. Ltd. China
Investment Building, No.235 HongQi Street,
High and New Technology Development Zone,
Harbin, HeilLongjiang Province, China
86 451 82262828
hs huashen.net
www.huashen.net
Product of China
Distributed By:
Exclusive Representation Center of
Huashen Corporation
1635 Bath Ave
Brooklyn, NY 11214
718 841 7770
www planethuashen comPackage Label.Principal Display Panel
HuaShen Pain Relieving Patch
Continuous Relief for up to
48
hours
- fast
- effective
- natural
5 Adhesive Patches with Menthol
Huashenpainrelievingpatch (Painrelievingpatch)
* Please review the disclaimer below.
