Astrapharm Chilli Brand Plaster
FDA Label NDC 11993-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dersan Pharmaceutical Co., Ltd for the product Astrapharm Chilli Brand (NDC 11993-000). 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 active ingredients, otc - ask doctor, keep out of reach of children, directions:, other information:, inactive ingredients:, questions or comments?, purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Capsaicin 0.25%..............................External analgesic

Otc - Ask Doctor

Stop use and ask doctor if

Keep Out Of Reach Of Children

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

Directions:

  • Clean and dry affected area, peel plaster away from paper backing and apply to the affected area by pressing edges down firmly.
  • If needed, cut plaster into smaller pieces.
  • Adults and children 12 years of age and over: Apply to affected area not more than 3 times daily. Children under 12 years, consult doctor before use.

Other Information:

  • Once opened, keep the unused plaster in an air-tight container.
  • Store at 20-25°C(68-77°F)

Inactive Ingredients:

Beta-pinene homopolymer, calcium carbonate, light steam-cracked aromatic naphtha(petroleum), polybutenes, rubber(natural), synthetic iron oxide, and zinc oxide

Questions Or Comments?

M-F, 9 am to 5 pm Pacific Time

  • You may also report serious side effects to this phone number.

Purpose

External analgesic

Do Not Use

  • on wounds
  • damaged or irritated skin

When Using This Product

  • avoid contact with the eyes or mucous membranes
  • do not bandage tightly
  • may cause rash or festering. Not recommended for people with sensitive skin.
  • burning sensation may occur. Not recommended for use when in contact with hot water.
  • highly adhesive plaster may hurt skin upon removal of product. Do not apply on hairy surface of skin.

Stop Use And Ask A Doctor If

  • Excessive irritation of the skin develops
  • Condition worsens
  • Symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • When using for pain of arthritis:
  •    if redness is present
  •    in conditions affecting children under 12 years of age  

Uses:

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 7In

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Inner Package 4.5In X 7In

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Astrapharm "Chilli Brand" External Analgesic Plaster 4.5In X 3.4In

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Inner Package 4.5In X 3.5In

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