Pain Reliefpatches
FDA Label NDC 53043-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Aquagel Bio-plymer Co., Ltd for the product Pain Reliefpatches (NDC 53043-001). 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, indications & usage, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

For External Use Only

DL-Camphor 1.2%.......................................................................................................................................Topical analgesic

L-Menthol 4.0%..........................................................................................................................................Topical analgesic

Methyl Salicylate 6.3%................................................................................................................................Topical analgesic

Otc - Purpose

Uses

For temporary relief of minor aches and pains associated with:

Arthritis

Backaches

Sprains

Strains

Bruises

Warnings

Warnings

For External Use Only

Indications & Usage

Do not use

other than as directed on wounds, damaged or irritated skin in combination with other external analgesic

products, ointments, creams or with a heating pad. in contact with eyes or mucous membranes. if you are

allergic to any ingredient in this product. if you have a history of allergic reactions to this or similar products

Otc - Stop Use

Stop Use and ask a doctor if

rash, itching or excessive skin irritation develops

condition worsens

symptoms persist for more than 7 days

if symptoms subside and then reappear 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 immediately.

Dosage & Administration

Directions

Adults and children 12 years of age and over: Clean and dry the affected area. Remove patch from film backing. Adhere

to area for no more than 8 hours at a time, not more than 3 times per day, and for no more than 7 days continuously.

Children under 12 years of age: Consult a doctor before use.

Storage And Handling

Other information

Store in a cool dry place. Avoid direct sunlight.

Inactive Ingredient

Inactive ingredients Ammonium Stearate, Calcium Carbonate, Glyceryl Abietate, Isopropyl Myristate, Natural

Rubber, Polybutene, Polyisobutylene, Propylene Carbonate, Styrene Copolymer, YS Resin, Zinc Oxide

Package Label.Principal Display Panel

Image Of Label (Pain Relief Patchlabel)

Image Of Label (Pain Relief Patchlabel)

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