FDA.reportPublic FDA data

DANDRUFF

Manufacturer
PLYMOUTH HEALTHCARE PRODUCTS LLC
Effective date
2021-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:20:09

Label at a glance#

ProductDANDRUFF
Active ingredientPOTASSIUM BROMIDE, POTASSIUM CHLORIDE, POTASSIUM SULFATE, SODIUM CHLORIDE, SULFUR, OYSTER SHELL CALCIUM CARBONATE, CRUDE, NICKEL SULFATE HEXAHYDRATE
Label structure9 sections

Indications and uses

Uses: For the temporary relief of Dandruff symptoms.** The claims for this product are based upon traditional homeopathic practice. They have not been reviewed by the FDA.

Dosage and administration

Directions:  Adults & Children 50 lbs & Up: Take ONCE per day as indicated on the chart below according to your weight: Weight  Daily Dosage 50 - 100 lbs ...................... (2) Pills Daily 100 - 150 lbs .................... (4) Pills Daily 150 - 200 lbs .................... (6) Pills Daily 200 - 250 lbs .................... (8) Pills Daily Over 250 lbs ..................... (10) Pills Daily Swallow whole. Fo...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS / PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (HPUS*) in each 750mg PillPurpose** 
 Kali Bromatum 1X HPUSItching, Scaling & Redness 
 Kali Muriaticum 1X HPUSDry, White Scales 
 Kali Sulphuricum 1X HPUSFlaking 
 Natrum Muriaticum 1X HPUSOily Scalp, Itchy, Burning Scalp
 Sulphur 1X HPUSDry, Scaly, Itchy Skin & Scalp 
 Calcarea Carbonica 3X HPUSWhite, Crusty Scales 
 Niccolum Sulphuricum 3X HPUSSkin Itching 

USES

INDICATIONS & USAGE SECTION

Uses: For the temporary relief of Dandruff symptoms.** The claims for this product are based upon traditional homeopathic practice. They have not been reviewed by the FDA.

WARNINGS

WARNINGS SECTION

Warnings:

 DO NOT USE

  • if you have kidney disease
  • in children under 12 years old
  • children under 50 lbs
  • if pregnant

Ask a doctor before use if

  • you have a known sensitivity to nickel or costume jewelry
  • a known sensitivity to any ingredients in this product

Stop use and ask a doctor if

  • skin rash appears
  • feelings of nervousness occur
  • if condition worsens or does not improve after regular use of this product
 If pregnant, do not use.
If breast-feeding, ask a doctor before use.
Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions: Adults & Children 50 lbs & Up:

Take ONCE per day as indicated on the chart below according to your weight:

Weight Daily Dosage

50 - 100 lbs ...................... (2) Pills Daily

100 - 150 lbs .................... (4) Pills Daily

150 - 200 lbs .................... (6) Pills Daily

200 - 250 lbs .................... (8) Pills Daily

Over 250 lbs ..................... (10) Pills Daily

Swallow whole. For optimal absorption, take orally at bedtime or in the morning - on an empty stomach. Do not eat or drink anything but water for 1 hour after taking.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information:TAMPER EVIDENT - for your protection, this bottle has an imprinted seal around the neck. DO NOT USE if imprinted tamper evident seal band is broken or missing.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Fumaric Acid, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Natural Blueberry Flavor, Organic Spirulina Powder, Sucrose.

QUESTIONS or COMMENTS?

OTC - QUESTIONS SECTION

Questions or Comments?

Call 800-316-9636, Monday through Friday, 9am-5pm EST or visit www.lomalux.com

Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon, OH 44139 USA

OTHER SAFETY INFORMATION

WE TARGET DANDRUFF AT ITS SOURCE - FOR HEALTHY SCALP FROM WITHIN

Dandruff Pill works from the inside out to provide scalp relief from within. Just like your daily vitamin, Dandruff Pill is taken orally. With just one daily dose, Dandruff Pill's active mineral ingredients help relieve Dandruff symptoms.

NATURE CREATED - DERMATOLOGIST PERFECTED

We use only the finest quality ingredients in our exclusive formulation developed by our dermatologist founder to promote scalp health from within. A perfect blend of science and nature.

MADE IN THE USA

NATURAL active ingredients

LACTOSE FREE

VEGAN

GLUTEN FREE

EXCLUSIVE MINERAL TECHNOLOGY PROMOTES SCALP HEALTH

7 Active Mineral Ingredients help relieve dandruff symptoms of flaking, itchy scalp, dryness, and irritation. These unique inorganic minerals are all natural, earth derived.


WHEN USED REGULARLY, MAY HELP RELIEVE SYMPTOMS OF DANDRUFF

DERMATOLOGISTS DEVELOPED, FOR HEALTHY SKIN FROM WITHIN

UNIQUE! - CUSTOMED DOSAGE ACCORDING TO YOUR WEIGHT FOR OPTIMAL RESULTS

A 12 WEEK USE COURSE IS RECOMMENDED. CONTINUE TAKING AS LONG AS BENEFICIAL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 61480-310-01

LOMALUX LABORATORIES

DANDRUFF PILL™

HEALTHY SCALP FROM WITHIN™

Relieves Symptoms of Dandruff:

Itchy Scalp

Dryness/Irritation

Flaking

Oily Scalp

Promotes Scalp Health

HOMEOPATHIC ORAL MEDICATION

DERMATOLOGIST DEVELOPED

1 DAILY DOSE

144 PILLS

carton labelcarton labelbottle labelbottle label

OTC - PURPOSE SECTION

Relieves Symptoms of Dandruff:

Itchy Scalp

Dryness/Irritation

Flaking

Oily Scalp

Promotes Scalp Health

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61480-31061480-310-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FUMARIC ACID88XHZ13131IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
BLUEBERRY253RUG1X1AIACT
SPIRULINA PLATENSIS9L3TIH1UUEIACT
SUCROSEC151H8M554IACT
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM CHLORIDE660YQ98I10ACTIM
POTASSIUM SULFATE1K573LC5TVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SULFUR70FD1KFU70ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
NICKEL SULFATE HEXAHYDRATEJC9WZ4FK68ACTIB

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
440c8636-f6f5-9387-e063-6294a90a6120212d6cbd-046d-40a5-b7dd-51b59d30b2012025-11-20WarningsExact identifier
spl set id: 212d6cbd-046d-40a5-b7dd-51b59d30b201

Reported adverse events (FAERS/openFDA)#

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