Calgonate Calcium Gluconate Gel 2.5% (Calcium Gluconate) Gel [Denison Pharmaceuticals, Llc] -

CALGONATE CALCIUM GLUCONATE GEL 2.5% (CALCIUM GLUCONATE) GEL [DENISON PHARMACEUTICALS, LLC]
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NDC	0295-7520-40
Set ID	8503ad98-0f83-2a2d-e053-2a91aa0aa36a
Category	HUMAN OTC DRUG LABEL
Packager	Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number

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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

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

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

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

Labeler - Denison Pharmaceuticals, LLC (001207208)

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

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