CALGONATE CALCIUM GLUCONATE GEL 2.5%- calcium gluconate gel 
Denison Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Calgonate

Active ingredients

Calcium Gluconate, 2.5%

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

Purpose

First aid response to hydrofluorix acid (HF) exposure

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 ingredients

Purified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide

Intended Use:

Topical skin treatment for hydrofuoric acid burns or exposure.

Warnings

Do not use if tube is damaged or open.

Re-use risks: contamination, low product efficacy.

cartoninsert

CALGONATE CALCIUM GLUCONATE GEL  2.5%
calcium gluconate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-7520
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM GLUCONATE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-7520-4025 g in 1 BOTTLE; Type 0: Not a Combination Product03/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/26/2019
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-7520)

Revised: 3/2019
Document Id: 8503ad98-0f84-2a2d-e053-2a91aa0aa36a
Set id: 8503ad98-0f83-2a2d-e053-2a91aa0aa36a
Version: 1
Effective Time: 20190326
 
Denison Pharmaceuticals, LLC