CALGONATE CALCIUM GLUCONATE GEL 2.5%- calcium gluconate gel

Calgonate Calcium Gluconate Gel by

Drug Labeling and Warnings

Calgonate Calcium Gluconate Gel by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Calcium Gluconate, 2.5%

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose

First 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 ingredients

Purified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide

INDICATIONS & USAGE

Intended Use:

Topical skin treatment for hydrofuoric acid burns or exposure.

WARNINGS

Warnings

Do not use if tube is damaged or open.

Re-use risks: contamination, low product efficacy.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALGONATE CALCIUM GLUCONATE GEL  2.5%
calcium gluconate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-7520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM GLUCONATE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-7520-40	25 g in 1 BOTTLE; Type 0: Not a Combination Product	03/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/26/2019

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-7520)