MedPath

Schuessler Tissue Salts Kali Sulph Skin Balance 7

Approved
Approval ID

0fa37814-6c70-4834-a0dc-5e729b80f3e5

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

Martin & Pleasance Pty Ltd

DUNS: 752869859

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Kali Sulphuricum

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84999-007
Product Classification
G
Generic Name
Kali Sulphuricum
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (4)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SULFATEActive
Quantity: 6 [hp_X] in 30 mL
Code: 1K573LC5TV
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/1/2025

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/27/2025

Uses

Temporarily relieves symptoms associated with:

  • Dry, scaly skin
  • Minor skin eruptions
  • Dandru­ff

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/1/2025

Inactive Ingredients

Alcohol, Glycerin, Purified Water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/1/2025

** Active Ingredients****Purpose**

Kali Sulphuricum 6X dry, scaly skin, minor skin eruptions,dandruff

“ HPUS” is the Homeopathic Pharmacopoeia of the United States

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/27/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 6/27/2025

Warnings

Stop use and ask a doctor if

• Symptoms persist for more than 7 days or worsen

• Inflammation, fever or infection is present or develops

• Fever gets worse or lasts more than 3 days If skin eruptions are severe, or painful, seek the advice of a doctor.

If pregnant or breastfeeding, ask a health professional before use.Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/27/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/27/2025

Directions

  • Use as directed
  • Take 30 minutes away from food.

Adults

  • Acute dose: Spray into the mouth 4 times every 30 mins until symptoms subside, up to 8 times per day.
  • Maintenance dose: Spray into mouth 4 times, 4 times per day.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/27/2025

**Questions?**www.schuesslertissuesalts.co or + 1-888-464-6775

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Schuessler Tissue Salts Kali Sulph Skin Balance 7 - FDA Drug Approval Details