NDC 0295-7520 Calgonate Calcium Gluconate Gel 2.5%

Calcium Gluconate

NDC Product Code 0295-7520

NDC 0295-7520-40

Package Description: 25 g in 1 BOTTLE

NDC Product Information

Calgonate Calcium Gluconate Gel 2.5% with NDC 0295-7520 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Calgonate Calcium Gluconate Gel 2.5% is calcium gluconate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Calgonate Calcium Gluconate Gel 2.5% Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CALCIUM GLUCONATE 2.5 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARBOMER 934 (UNII: Z135WT9208)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Denison Pharmaceuticals, Llc
Labeler Code: 0295
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-26-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Calgonate Calcium Gluconate Gel 2.5% Product Label Images

Calgonate Calcium Gluconate Gel 2.5% Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredientsCalcium Gluconate, 2.5%

Otc - Keep Out Of Reach Of Children

Keep out of Reach of Children. For external use only. Avoid contact with eyes.

Otc - Purpose

PurposeFirst aid response to hydrofluorix acid (HF) exposure

Dosage & Administration

Directions Before applying gel, rinse area with water. Invert cap and pierce metal seal to open tube. Apply gel freely, massage in. Reapply gel every 10 to 15 minutes while seeking emergency medical assistance.

Inactive Ingredient

Inactive ingredientsPurified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide

Indications & Usage

Intended Use:Topical skin treatment for hydrofuoric acid burns or exposure.

Warnings

WarningsDo not use if tube is damaged or open. Re-use risks: contamination, low product efficacy.

* Please review the disclaimer below.

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