NDC | 66096-728-08 |
Set ID | df1dba42-d7f7-4299-85e4-999c6a91c76d |
Category | HUMAN OTC DRUG LABEL |
Packager | OHM PHARMA INC. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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
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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.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DANDRUFF RELIEF
baptisia tinctoria, borax, calendula, candida albicans, eugenia caryophyllata,fucus vesiculosus, kali iodatum, symphytum officinale, thuja occidentalis. shampooProduct 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)