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General Labeling Requirements

  • Proper labeling is crucial for ensuring that consumers have accurate and essential information about the drugs and cosmetics they use.

  • The Drugs and Cosmetics Act, 1940 lays out comprehensive labeling standards to safeguard public health.

Key Labeling Components:

Name of the Drug/Cosmetic:

  • Must clearly state the brand and generic names.

Net Quantity:

  • The amount of the product contained in the package (e.g., milliliters, grams).

Batch Number:

  • Unique identifier for tracking and quality control.

Date of Manufacture and Expiry:

  • Manufacturing date (Mfg. Date) and expiry date (Exp. Date) must be clearly mentioned.

Name and Address of Manufacturer:

  • Full details of the manufacturing entity.

Standard Description:

  • Detailed description of the product, including its composition and intended use.

License Number:

  • The manufacturer's license number as issued under the Act.

Storage Instructions:

  • Guidelines on how to store the product to maintain its efficacy.

Directions for Use:

  • Instructions on how to use the product safely and effectively.

Precautions and Contraindications:

  • Warnings about potential side effects or situations where the product should not be used.

List of Ingredients:

  • Comprehensive list of all active and inactive ingredients.

Warnings:

  • Specific warnings related to the product's use, such as "Keep out of reach of children."

Instructions for Disposal:

  • Guidelines on how to properly dispose of the product after use or if it becomes ineffective.


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