MedPath

Schuessler Tissue Salts Comb D Skin Disorders

Approved
Approval ID

03153d92-dc68-4b84-a8c9-634b1ffd7da1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 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 Muriaticum,Kali Sulphuricum,Calcarea Sulphurica,Silicea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84999-026
Product Classification
G
Generic Name
Kali Muriaticum,Kali Sulphuricum,Calcarea Sulphurica,Silicea
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (7)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 6 [hp_X] in 1 1
Code: 660YQ98I10
Classification: ACTIM
POTASSIUM SULFATEActive
Quantity: 6 [hp_X] in 1 1
Code: 1K573LC5TV
Classification: ACTIB
CALCIUM SULFATE DIHYDRATEActive
Quantity: 6 [hp_X] in 1 1
Code: 4846Q921YM
Classification: ACTIB
SILICON DIOXIDEActive
Quantity: 6 [hp_X] in 1 1
Code: ETJ7Z6XBU4
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/5/2025

Product label

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/5/2025

Uses

Temporarily relieves symptoms associated with

  • Skin disorders
  • Minor skin eruptions
  • Acne
  • Dry, scaly & flaky skin

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/5/2025

Active Ingredients Purpose

Calcarea Sulphurica 6X HPUS ............................................ skin disorders, acne
Kali Muriaticum 6X HPUS...................................................minor skin eruptions
Kali Sulphuricum 6X HPUS...............dry, scaly & flaky skin, minor skin eruptions
Silicea 6X HPUS......................................... skin disorders, minor skin eruptions

" HPUS" is the Homeopathic Pharmacopoeia of the United States

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/5/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 8/5/2025

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: 8/5/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/11/2025

Directions

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

Adults:

  • Acute dose: Chew 1 tablet every 30 minutes until symptoms subside, up to 6 times per day.
  • Maintenance dose: Chew 1 tablet, 4 times daily.

Children 6 years and older:

  • Acute dose: Crush ½ tablet, dissolve in water, and take every 30 minutes until symptoms subside, up to 6 times per day.
  • Maintenance dose: Crush ½ tablet, dissolve in water, 4 times per day.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 8/5/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/5/2025

Inactive Ingredients

Calcium hydrogen phosphate, Lactose, Magnesium stearate.

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Schuessler Tissue Salts Comb D Skin Disorders - FDA Drug Approval Details