Camphor
FDA Label NDC 10095-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by World Perfumes, Inc for the product Camphor (NDC 10095-003). 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, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, 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 ............. Purpose

Camphor 10% ............. Topical Analgesic

Otc - Purpose

Uses

  • Temporary relief of minor pain
  • Rheumatism
  • Muscular Aches
  • Arthritis
  • Backache

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

Indications & Usage

Camphor Ointment

External Use Only

Temporary relief of minor pains:

Muscular Aches | Arthritis

Rheumatism | Backache

Dosage & Administration

Directions - Adults and children 10 years of age and older: apply in affected area not more than 3 times daily.

Warnings

Warning - For external use only.

In case of accidental ingestion, get help or contact a poison control center immediately.

Do not use

  • on irritated skin
  • in or near eyes or mucous membranes
  • on wounds or damaged skin
  • if prone to allergic reaction from any ingredient
  • on large area of the body

    • Ask a doctor or pharmacist before use if you are taking any other medication or drinking alcohol. Stop use and ask a doctor if condition worsens or clears up and occurs again, if symptoms persist for more than 7 days or irritation or severe burning occurs. If pregnant or breast-feeding ask a health professional before use. Keep at room temperature.

Inactive Ingredient

Inactive Ingredients Petrolatum

Package Label.Principal Display Panel

Label Image (Camphor)

Label Image (Camphor)

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