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This document provides the final monograph for over-the-counter antiperspirant drug products, establishing safety, effectiveness, labeling requirements, and active ingredient specifications regulated

How to fill out antiperspirant drug products for

How to fill out Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph

1. Review the Final Monograph for Antiperspirant Drug Products for Over-the-Counter Human Use to understand the regulatory requirements.
2. Gather necessary data on your product formulation, including active ingredients, inactive ingredients, and their concentrations.
3. Prepare labeling materials that meet the labeling requirements laid out in the monograph, including drug facts, usage instructions, warnings, and ingredients.
4. Conduct stability testing to establish the shelf life of the product and ensure its efficacy over time.
5. Perform any required clinical testing, such as dermatological tests, to ensure safety and effectiveness for consumer use.
6. Compile all documentation, including test results and manufacturing processes, to support your New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
7. Submit your application to the appropriate regulatory body for approval and await feedback or necessary revisions.

Who needs Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

1. Consumers looking for effective over-the-counter solutions to control perspiration and body odor.
2. Individuals with hyperhidrosis or excessive sweating seeking convenient over-the-counter products.
3. Retailers and wholesalers who stock personal care products for consumers.
4. Manufacturers of personal care products who want to create compliant antiperspirant goods.

People Also Ask about

What antiperspirant do doctors prescribe?

Driclor: Driclor is a roll-on antiperspirant with 20 percent aluminum chloride. Doctors typically prescribe Driclor for axillary and palmoplantar hyperhidrosis (hands and feet). Drysol: A prescription-only option, Drysol is on the stronger side with 20 percent aluminum chloride.

What category is antiperspirant?

A subclass of deodorants, called antiperspirants, prevents sweating itself, typically by blocking sweat glands. Antiperspirants are used on a wider range of body parts, at any place where sweat would be inconvenient or unsafe, since unwanted sweating can interfere with comfort, vision, and grip (due to slipping).

Is antiperspirant an OTC drug?

Anti-perspirants are regulated by the FDA and are considered over-the-counter (OTC) drugs. The active ingredient must be an approved aluminum compound, and the labeling must include Drug Facts as outlined in the OTC monograph, which provides the FDA “rules” for anti-perspirants.

Is antiperspirant considered a drug?

Anti-perspirants/Deodorants These combination products are very common. The anti-perspirant component still requires an approved aluminum compound as the active ingredient. Because of this, all anti-perspirant/deodorant products are considered OTC drugs and are regulated by the FDA.

What is an example of an antiperspirant drug?

Antiperspirants work by blocking the sweat glands, which reduces the amount of sweat that reaches the skin's surface. These products come in different forms, including topical solutions and roll-ons. Examples include aluminum chloride hexahydrate (Drysol, Xerac AC).

What drug is antiperspirants?

Topical aluminum chloride is commonly used as an antiperspirant to treat excessive sweating of the underarms, hands, or feet. Topical aluminum chloride may also be used for other conditions as determined by your healthcare provider.

For pdfFiller’s FAQs

What is Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

The Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph is a set of regulations established by the FDA that outlines the standards for safety and efficacy for antiperspirant products sold over-the-counter.

Who is required to file Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

Manufacturers and distributors of antiperspirant products that intend to market these items over-the-counter must file the necessary information with the FDA in compliance with the Final Monograph.

How to fill out Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

To fill out the Final Monograph, manufacturers must provide detailed information about the product formulation, safety data, labeling, and any clinical studies demonstrating the product's effectiveness as specified by the FDA.

What is the purpose of Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

The purpose of the Final Monograph is to ensure that antiperspirant products are safe for public use, effective in reducing perspiration, and properly labeled for consumers.

What information must be reported on Antiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph?

The information that must be reported includes the product's active ingredients, concentrations, safety and efficacy data, manufacturing processes, labeling claims, and any relevant studies that support the product's intended use.