Active Ingredient:
CALCAREA SULPHURICA 6X**
Calcarea Sulphurica Pellet
FDA Label NDC 76472-4090
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sevene Usa for the product Calcarea Sulphurica (NDC 76472-4090). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient:, traditionally used for temporary relief from:, directions:, uses:, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Traditionally Used For Temporary Relief From:
Pustular acne, itchy and irritated skin, and joint health*
*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Directions:
- (Adults/Children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.
Uses:
Pustular acne, itchy and irritated skin, and joint health**.
**C, K, CK & X are homeopathic dilutions.
Warnings
- Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
Otc - Pregnancy Or Breast Feeding
- If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
- In case of overdose, get medical help.
Other Information:
- Store at room temperature.
- Do not use if tamper-evidence seal is broken.
- Organic verified by Alpes Control 2021/A03M216K/1.
Inactive Ingredient:
ORGANIC SUCROSE
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