DANDRUFF RELIEF- baptisia tinctoria, borax, calendula, candida albicans, eugenia caryophyllata,fucus vesiculosus, kali iodatum, symphytum officinale, thuja occidentalis. shampoo

Dandruff Relief by

Drug Labeling and Warnings

Dandruff Relief by is a Homeopathic medication manufactured, distributed, or labeled by OHM PHARMA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

WARNINGS

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.

• ​KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

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

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

QUESTIONS

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

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

Dandruff

INGREDIENTS AND APPEARANCE

DANDRUFF RELIEF 
baptisia tinctoria, borax, calendula, candida albicans, eugenia caryophyllata,fucus vesiculosus, kali iodatum, symphytum officinale, thuja occidentalis. shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66096-728
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	1 [hp_X]  in 240 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	1 [hp_X]  in 240 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 240 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	30 [hp_X]  in 240 mL
CLOVE (UNII: K48IKT5321) (CLOVE - UNII:K48IKT5321)	CLOVE	1 [hp_X]  in 240 mL
FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M)	FUCUS VESICULOSUS	1 [hp_X]  in 240 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	2 [hp_X]  in 240 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	6 [hp_X]  in 240 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	1 [hp_X]  in 240 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDE (UNII: 3YXD33R71G)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
DISODIUM LAURYL SULFOSUCCINATE (UNII: P160Q81342)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
SESAME OIL (UNII: QX10HYY4QV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
TEA TREE OIL (UNII: VIF565UC2G)
WHEAT GERM OIL (UNII: 14C97E680P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66096-728-08	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/02/2015

Labeler - OHM PHARMA INC. (030572478)

Registrant - OHM PHARMA INC. (030572478)

Establishment
Name	Address	ID/FEI	Business Operations
OHM PHARMA INC.		030572478	manufacture(66096-728)