Plaster
FDA Label NDC 14319-3118

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dah Wei Chem & Pharm Co., Ltd. for the product Plaster (NDC 14319-3118). 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, indications & usage, warnings, dosage & administration, storage and handling, inactive ingredient, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients: (each 5 g patch contains)                                 PURPOSE
METHYL SALICYLATE  250 mg                                         EXTERNAL ANALGESIC
L-METHENOL -  200 mg                                                    EXTERNAL ANALGESIC
CAMPHOR –   40mg                                                         EXTERNAL ANALGESIC
SESAME OIL – 500 mg                                                     EXTERNAL ANALGESIC
MYRRH – 150mg                                                              EXTERNAL ANALGESIC                                     
                                  

Indications & Usage

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis strains, bruises and sprains.

Warnings

For external use only

Dosage & Administration

Remove the clear backing and apply to thew sore area of skin.

Storage And Handling

■ Keep container tightly closed, once opened, fold the opening and keep pressed closed with a clip.
■ Store at room temperature.

Inactive Ingredient

Inactive ingredient: Resin

Otc - Ask Doctor


Stop use and ask a doctor if:
■ Condition worsens
■ Symptom clear up and occur again within a few days.
■ Symptom persist for more than 7 days.
■ Nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs
■ Excessive irritation of the skin develops
■ When using for pain of arthritis:
■ In conditions affecting children under 12 years of age
■ If red nose is present
■ If pain persists for more than 10 days 

Otc - Keep Out Of Reach Of Children

Keep out reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

Otc - Do Not Use

Do not use:
■ On wounds
■ On infected or damaged skin
When using this product:
■ Avoid contact with eyes or mucous membranes.
■ Do not bandage tightly.

Purpose

EXTERNAL ANALGESIC

Package Label.Principal Display Panel

Mandaherbalplaster (Mandaherbalplaster)

Mandaherbalplaster (Mandaherbalplaster)

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