Overview
Zinc sulfate is the inorganic compound with the formula ZnSO4 and historically known as "white vitriol". It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system.
Indication
This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT). It is also used as a topical astringent. Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN.
Associated Conditions
- Dry Eyes
- Local itching
- Localized pain
- Localized swelling
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/25 | Phase 3 | Completed | |||
2024/08/19 | Phase 2 | Recruiting | |||
2024/08/16 | Not Applicable | Completed | dr. Aldora Jesslyn Oentari | ||
2024/07/24 | Phase 4 | Not yet recruiting | Amira Adel Fouly | ||
2024/07/01 | Phase 2 | Completed | |||
2024/05/30 | Phase 3 | Not yet recruiting | |||
2022/05/27 | Phase 2 | UNKNOWN | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2022/04/05 | Phase 4 | Completed | Zekai Tahir Burak Women's Health Research and Education Hospital | ||
2021/12/17 | Not Applicable | Completed | |||
2020/05/01 | Phase 4 | Completed | St. Francis Hospital, New York |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 65219-403 | INTRAVENOUS | 3 mg in 1 mL | 12/12/2022 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1877 | INTRAVENOUS | 3 mg in 1 mL | 8/31/2023 | |
| PureTek Corporation | 59088-112 | ORAL | 18.2 mg in 1 1 | 1/11/2023 | |
| Discount Drug Mart, Inc. | 53943-490 | OPHTHALMIC | 0.25 g in 100 mL | 1/1/2024 | |
| American Regent, Inc. | 0517-6103 | INTRAVENOUS | 3 mg in 1 mL | 10/1/2020 | |
| Piramal Critical Care Inc. | 66794-239 | INTRAVENOUS | 25 mg in 5 mL | 12/21/2023 | |
| Zydus Pharmaceuticals USA Inc. | 70710-1878 | INTRAVENOUS | 5 mg in 1 mL | 8/31/2023 | |
| Zydus Lifesciences Limited | 70771-1849 | INTRAVENOUS | 3 mg in 1 mL | 8/31/2023 | |
| Gland Pharma Limited | 68083-608 | INTRAVENOUS | 1 mg in 1 mL | 9/7/2023 | |
| Fresenius Kabi USA, LLC | 65219-401 | INTRAVENOUS | 1 mg in 1 mL | 12/12/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION | SIN16135P | INJECTION, EMULSION | 0.0066g/1000ml | 3/24/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| METAGENICS ZINC DRINK | 64051 | Medicine | A | 4/27/1998 | |
| MOUTH ULCER | 343446 | Medicine | A | 9/14/2020 | |
| Kids Immunity Boost | 456171 | Medicine | A | 7/24/2024 | |
| Recoverthol | 291026 | Medicine | A | 7/5/2017 | |
| HOPEPLUS PEAK FORMULA FOR YOU TRIBULUS TERRESTRIS LIQUID oral liquid bottle | 74818 | C & W International Development (Holding) Pty Ltd | Medicine | A | 6/14/2000 |
| OPTHALMIC LABS ZINC SULFATE 50mg/1mL Injection | 22857 | Medicine | A | 10/14/1991 | |
| Conceive Plus Women's Fertility Support | 347979 | Medicine | A | 11/11/2020 | |
| Frequent Flyer Immunity Boost | 406538 | Medicine | A | 3/21/2023 | |
| NRGY Sports Relief | 129942 | ProSports Nutrition Pty Ltd | Medicine | A | 8/2/2006 |
| Frequent Flyer Immunity Boost (Raspberry Flavour) | 410130 | Medicine | A | 6/6/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ZINCUM SULFURICUM | dolisos canada inc. | 02234804 | Granules
,
Globules
,
Liquid - Oral | 3 X | 1/5/1998 |
| HEMORRHOIDAL OINTMENT WITH ANESTHETIC FOR EXTRA PAIN RELIEF | cellchem pharmaceuticals inc. | 02295865 | Ointment - Rectal | 0.5 % / W/W | N/A |
| ALLERGY EYE DROPS | juno otc inc | 02290596 | Solution - Ophthalmic | 0.25 % / W/V | 5/23/2007 |
| ANUSOL-HC OINTMENT | church & dwight canada corp | 00505773 | Ointment - Rectal | 0.5 % | 12/31/1981 |
| VISINE A.C. OPHTHALMIC SOL | pfizer canada inc., consumer healthcare division | 01942433 | Liquid - Ophthalmic | .25 % | 12/31/1981 |
| ZINCUM SULFURICUM GRANULE (3DH-30DH) | homeocan inc. | 01955160 | Tablet - Oral | 3 DH / TAB | 12/31/1991 |
| ZINCUM SULFURICUM-INJEEL LIQ (10D,30D,200D/1.1ML) | 02051370 | Liquid - Oral | 10 D / 1.1 ML | 12/31/1993 | |
| RECTOGEL HC | laboratoire riva inc. | 00662461 | Ointment - Rectal | 0.5 % | 5/26/1998 |
| MULTI VITAMIN MINERAL TAB | nutristar health products (1987) inc. | 00474800 | Tablet - Oral | 1.5 MG / TAB | 12/31/1979 |
| ANUSOL PLUS OINTMENT | church & dwight canada corp | 01945912 | Ointment - Rectal
,
Topical | 0.5 % | 12/31/1992 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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