FDA.reportPublic FDA data

CALCAREA SULPHURICA

Manufacturer
Washington Homeopathic Products
Effective date
2018-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:11

Label at a glance#

ProductCALCAREA SULPHURICA
Active ingredientCALCIUM SULFATE ANHYDROUS
Label structure9 sections

Indications and uses

Boils Acne

Dosage and administration

Adults: Dissolve 2-4 tablets under the tongue 3 times a day. Children: Half the adult dose. Repeat at greater intervals as condition subsides, or as directed by a licensed practitioner.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (HPUS):

Calcarea sulphurica 6X

The letters “HPUS” indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES

OTC - PURPOSE SECTION

  • Boils
  • Acne

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all medications, keep out of reach of children.

INDICATIONS

INDICATIONS & USAGE SECTION

Indications:

Relief of symptoms of boils, pimples and acne.*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

STOP USE AND ASK DOCTOR

WARNINGS SECTION

If symptoms worsen or persist for more than 7 days, or if pregnant or nursing, consult a licensed practitioner.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults: Dissolve 2-4 tablets under the tongue 3 times a day. Children: Half the adult dose. Repeat at greater intervals as condition subsides, or as directed by a licensed practitioner.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Lactose, Magnesium Stearate, Sodium Starch Glycolate

DO NOT USE

OTC - DO NOT USE SECTION

Do not use if seal is broken.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALCAREA SULPHURICA 6X

BoxBox

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71919-751-362022-03-25C16284748780-19d75b9cf-fac7-f424-e053-dadaa90a57ceCALCAREA SULPHURICA
71919-751-362020-01-31C16284748780-19d75b9cf-fac7-f424-e053-dadaa90a57ceCALCAREA SULPHURICA

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71919-75171919-751-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
MAGNESIUM STEARATE70097M6I30IACT
LACTOSEJ2B2A4N98GIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HACTIB

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
db0c43c0-1346-1ebd-e053-2a95a90a1ecc6dc89102-27c6-4970-e053-2a91aa0af4082022-03-25WarningsExact identifier
spl set id: 6dc89102-27c6-4970-e053-2a91aa0af408

Reported adverse events (FAERS/openFDA)#

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