Topicale Gel
Product Images NDC 10733-167

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Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Topicale (NDC 10733-167). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medical Products Laboratories, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Pump Label (Topicale Gel Cherry)

Pump Label (Topicale Gel Cherry)
This is a description of a topical anesthetic gel, specifically designed for external use only. It contains 18% Benzocaine in a glycol base. The product is manufactured by Premier Dental Products Company, located at 1710 Romano Drive, Plymouth Meeting, PA 19462, USA. It is important to note that individuals with a known hypersensitivity to benzocaine should avoid using this product. The gel should be kept out of reach of children. The manufacturer, Medical Products Laboratories, Inc., is based at 9990 Global Road, Philadelphia, PA 19115, USA. The product is packaged in a 43g (1.5 oz) container with a cherry flavor. The website for Premier Dental Products is www.premusa.com, and it is mentioned that the product is made in the USA. The NDC number for the product is 10733-167-43.*
FDA Label Image

Package Insert (Topicale Gel Insert)

Package Insert (Topicale Gel Insert)
Premier Topicale is a topical anesthetic gel that contains 18% Benzocaine, which provides temporary relief for minor pain and irritation associated with various conditions, such as canker sores, minor dental procedures, and irritation caused by dentures or orthodontic appliances. However, it is important to follow the warnings and directions provided. The gel should not be used in large quantities or over large areas of the body, and it is not suitable for children under 2 years of age or for teething purposes. If any severe symptoms such as pale or blue colored skin, headaches, rapid heart rate, or shortness of breath occur, immediate medical attention should be sought. Allergies to anesthetics like benzocaine should be considered and if any throat or mouth symptoms persist or worsen after using the gel, medical advice should be sought. The gel should not come in contact with the eyes and should be kept out of reach of children. In case of accidental overdose, medical help or a Poison Control Center should be contacted.*
FDA Label Image

Pump Label (Topicale Gel Pina Colada)

Pump Label (Topicale Gel Pina Colada)
This text is a description of a topical anesthetic gel called Premier Topicale. It contains 18% Benzocaine in a specially designed glycol base. It is not meant for injection, and should only be used topically. The gel is manufactured by Premier Dental Products Company, located at 1710 Romano Drive, Plymouth Meeting, PA 19462, USA. The gel should be kept out of reach of children. There is a warning that patients with a known history of hypersensitivity to benzocaine should not use the gel. The gel is made by Medical Products Laboratories, Inc., located at 9990 Global Road, Philadelphia, PA 19115, USA. The product is Pina Colada flavored and comes in a 43g (1.5 oz) container. The website for more information is www.premusa.com.*
FDA Label Image

Pump Label (Topicale Gel Raspberry)

Pump Label (Topicale Gel Raspberry)
This text is a description for a topical anesthetic gel containing 18% benzocaine in a specially designed glycol base. It is not meant for injection and should only be used externally. Patients with a known hypersensitivity to benzocaine should avoid using it. It is important to keep this product and all drugs out of the reach of children. The gel is manufactured for Premier Dental Products Company and Medical Products Laboratories, Inc., both located in Pennsylvania. The product is made in the USA and the website for Premier Dental is premusa.com. The NDC number for the product is 10733-169-43 and it comes in a 43g (1.5 oz) container.*
FDA Label Image

Pump Label (Topicale Gel Strawberry)

Pump Label (Topicale Gel Strawberry)
This text is a description of a topical anesthetic gel containing 18% Benzocaine. It states that the gel is not meant for injection and should only be used topically. It also mentions that individuals with a known hypersensitivity to Benzocaine should not use the product. The text provides information on the manufacturer, Premier Dental Products Company, and their address in Plymouth Meeting, PA. It also mentions the manufacturer of the gel, Medical Products Laboratories, Inc., and their address in Philadelphia, PA. The text advises keeping the product out of reach of children. The gel comes in a 43g (1.5 oz) net weight container, specifically the Strawberry variant. Overall, it appears to be a topical anesthetic gel containing Benzocaine for numbing purposes.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.