Calgonate Calcium Gluconate Gel

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2019-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:28:37

Label at a glance#

ProductCalgonate Calcium Gluconate Gel 2.5%
Active ingredientCALCIUM GLUCONATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Calcium Gluconate, 2.5%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Purpose

First aid response to hydrofluorix acid (HF) exposure

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients

Purified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide

INDICATIONS & USAGE SECTION

Intended Use:

Topical skin treatment for hydrofuoric acid burns or exposure.

WARNINGS SECTION

Warnings

Do not use if tube is damaged or open.

Re-use risks: contamination, low product efficacy.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartoninsertinsert

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0295-7520-40GM - Gram0295-75201a99b58c-6b2f-4a1c-862c-cb642ef73ff112023-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-75200295-7520-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8503ad98-0f84-2a2d-e053-2a91aa0aa36a8503ad98-0f83-2a2d-e053-2a91aa0aa36a2019-03-26WarningsExact identifier
spl id: 8503ad98-0f84-2a2d-e053-2a91aa0aa36a
spl set id: 8503ad98-0f83-2a2d-e053-2a91aa0aa36a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.