FDA.reportPublic FDA data

Dandruff Relief

Manufacturer
OHM PHARMA INC.
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:19:07

Label at a glance#

ProductDandruff Relief
Active ingredientBAPTISIA TINCTORIA ROOT, SODIUM BORATE, CALENDULA OFFICINALIS FLOWERING TOP, CANDIDA ALBICANS, CLOVE, FUCUS VESICULOSUS, POTASSIUM IODIDE, COMFREY ROOT, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Baptisia Tinctoria 1X, Borax 1X, Calendula 1X, Candida Albicans 30X, Eugenia Caryophylata 1X, Fucus Vesiculosus 1X, Kali Iodatum 2X, Symphytum Officinale 6X, Thuja Occidentalis 1X.

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves itchy, flaky scalp caused by dandruff.*

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

WARNINGS SECTION

WARNINGS: FOR TOPICAL USE ONLY. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than a week, discontinue use and contact a doctor. In case of overdose (or accidental ingestion) 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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Apply shampoo to wet hair, massage for 1 minute to stimulate the scalp. For better results keep the shampoo on for at least 2 minutes before rinsing thoroughly. Repeat if desired.

OTHER SAFETY INFORMATION

OTHER INFORMATION: TAMPER EVIDENT - Do not use if seal is broken or missing. Store at room temperature, in dark, cool place, away from direct sunlight.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Cocamide MIPA**, Cocamidopropyl Betaine**, Cocamidopropyl Hydroxysultaine**, Decyl Glucoside***, Disodium Laureth Sulfosuccinate**, Disodium Lauryl Sulfosucciante**, Magnesium Chloride (Natural Mineral), Oregano Essential Oil, Organic Aloe Vera Gel, Purified Water, Sesame Seed Oil, Sodium Chloride (Common Salt), Sodium Hydroxymethylglycinate (From Glycine & Amino Acid), Tea Tree Essential Oil, Wheat Germ Oil. **Derived from Coconut Oil ***Derived from Corn Starch & Coconut

OTC - QUESTIONS SECTION

QUESTIONS OR COMMENTS? Mfg. by: OHM PHARMA, INC. / Mineral Wells, TX 76067 / www.ohmpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 66096-664-08

OHM Dandruff Relief Shampoo

TOPICAL HOMEOPATHIC

8 fl oz (240 mL)

Made in USA

  • Balanced pH
  • Parabens Free
  • Propylene Glycol Free
  • Sodium Lauryl Sulfate Free
  • Synthetic Fragrance Free
  • Vegan - No Animal Ingredients

8oz bottle label8oz bottle label

OTC - PURPOSE SECTION

Dandruff

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-72866096-728-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDE3YXD33R71GIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
DISODIUM LAURYL SULFOSUCCINATEP160Q81342IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
OREGANO LEAF OIL7D0CGR40U1IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SESAME OILQX10HYY4QVIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
TEA TREE OILVIF565UC2GIACT
WHEAT GERM OIL14C97E680PIACT
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
SODIUM BORATE91MBZ8H3QOACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CLOVEK48IKT5321ACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
COMFREY ROOTM9VVZ08EKQACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB

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
2a0ef965-7511-4bd6-8900-6c667db8dc53df1dba42-d7f7-4299-85e4-999c6a91c76d2022-01-04WarningsExact identifier
spl id: 2a0ef965-7511-4bd6-8900-6c667db8dc53
spl set id: df1dba42-d7f7-4299-85e4-999c6a91c76d

Reported adverse events (FAERS/openFDA)#

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