Label: OHM-DETL- boldo, carduus marianus, chelidonium majus, china officinalis, cynara scolymus, hydrastis canadensis, nux vomica, stannum metallicum, taraxacum officinale spray
- NDC Code(s): 66096-719-02
- Packager: OHM PHARMA INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated February 18, 2020
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ACTIVE INGREDIENT
Active ingredients (HPUS*): Each 100 mL contains: Boldo 5X, Carduus Marianus 5X,
Chelidonium Majus 5X, China Officinalis 7X, Cynara Scolymus 5X, Hydrastis Canadensis 5X, Nux
Vomica 7X, Stannum Metallicum 16X, Taraxacum Officinale 5X; 3.30 mL each.
*The letters “HPUS” indicate the components in the product are officially monographed in the
Homeopathic Pharmacopoeia of the United States. - INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHM-DETL
boldo, carduus marianus, chelidonium majus, china officinalis, cynara scolymus, hydrastis canadensis, nux vomica, stannum metallicum, taraxacum officinale sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66096-719 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O) PEUMUS BOLDUS LEAF 5 [hp_X] in 30 mL MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE) MILK THISTLE 5 [hp_X] in 30 mL CHELIDONIUM MAJUS WHOLE (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS WHOLE 5 [hp_X] in 30 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 7 [hp_X] in 30 mL CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF 5 [hp_X] in 30 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 5 [hp_X] in 30 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 7 [hp_X] in 30 mL TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN 16 [hp_X] in 30 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 5 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66096-719-02 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/10/2020 Labeler - OHM PHARMA INC. (030572478) Registrant - OHM PHARMA INC. (030572478) Establishment Name Address ID/FEI Business Operations OHM PHARMA INC. 030572478 manufacture(66096-719)
