Overview
Potassium alum is considered by the FDA as a generally recognized as safe (GRAS) substance. It is an inorganic salt, also called potassium aluminum sulfate with a formula of AlK(SO4)2 that is predominantly produced in the dodecahydrate form (AlK(SO4)2 * 12H2O). Potassium alum is formed by large, transparent crystals that are used in different products like food or drugs as a buffer, neutralizing or forming agent.
Indication
Potassium alum is considered safe by the FDA and its use is in homepathic or OTC products. Due to its presence in several different drugs, the main indications for the use of potassium alum are: -Constipation -Cosmetic or drug astringent, helping the shrinkage of tissues and the dry of secretions -Oral health care drug -Part of formulation in cleansing products, skin-care products, mosturizers, face powders and deodorants -Antiperspirant -Antifungal
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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No clinical trials found
No clinical trials found for this drug
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
BM Private Limited | 85816-1025 | ORAL | 6 [hp_X] in 60 mg | 6/20/2025 | |
Bestmade Natural Products | 82969-1025 | ORAL | 6 [hp_X] in 6 [hp_X] | 5/26/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ALUMEN | homeocan inc. | 02233879 | Granules
,
Globules
,
Drops - Oral | 3 X | 1/24/1998 |
ALUMEN CRUDUM GRAN AND GLOB 3CH-30CH | dolisos laboratoires s.a. | 00792047 | Tablet - Oral | 3 CH / CH | 12/31/1988 |
GINGIYARN W ALUM POT SULF NO2 0.8MG/2.5CM | van r dental products inc. | 00572667 | Cord - Dental | .8 MG / 2.5 CM | 12/31/1981 |
GINGIBRAID W EPINEPH AND ALUM 1E | van r dental products inc. | 00572608 | Cord - Dental | 0.25 MG / 2.5 CM | 12/31/1981 |
SULPAK R 26 | north pacific dental inc. | 00551260 | Cord - Dental | .68 MG / CM | 12/31/1981 |
SULPAK R 25 | north pacific dental inc. | 00551252 | Cord - Dental | .244 MG / CM | 12/31/1981 |
HOMEOPATHIC MEDICINE (S NO. 253) DPS 30C | total health centre | 02077019 | Drops - Oral | 30 C / ML | 12/31/1994 |
ALUMEN CRUDUM | dolisos canada inc. | 02234295 | Liquid
,
Granules
,
Globules - Oral | 3 X | 1/5/1998 |
GINGICORD W EPINEPH AND ALUM SIZE NO 3 | van r dental products inc. | 00572713 | Cord - Dental | .95 MG / 2.5 CM | 12/31/1981 |
ALUM POWDERED | dawson traders ltd. | 00328049 | Powder - Oral | null NIL / NIL | 12/31/1977 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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No UK EMC drug information found for this drug. |
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