NDC | 69028-0002-1 |
Set ID | 6f412977-6313-bd76-e053-2991aa0aeb56 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Xymogen |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- KEEP OUT OF REACH OF CHILDREN SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- WARNINGS SECTION
- QUESTIONS? SECTION
- INACTIVE INGREDIENT SECTION
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ACTIVE INGREDIENT SECTION
Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x. Benzoicum ac.,15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Carduus ben.,15x, Carduus Mar. 15x, Ceanothus 15x, Chelidonium maj., 15x, Chionanthus 15x, Cinchona 15x, Dioscorea 15x, Dolichos 15x, Iris vers., 15x, Juniperus com.15x, Nux vom. 15x, Ptelea 15x, Taraxacum 15x, Uricum ac., 15x.
- DOSAGE & ADMINISTRATION SECTION
- INDICATIONS & USAGE SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
DRAINAGE
carduus mar., cynara, solidago, taraxacum, benzoicum ac., berberis vulg., bryonia, cantharis, carduus ben., ceanothus, chelidonium maj., chionanthus. cinchona, dioscorea, dolichos, iris vers., juniperus com., nux vom., ptelea, uricum ac. liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69028-0002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 15 [hp_X] in 1 mL BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA 15 [hp_X] in 1 mL CENTAUREA BENEDICTA (UNII: 6L5ZL09795) (CENTAUREA BENEDICTA - UNII:6L5ZL09795) CENTAUREA BENEDICTA 15 [hp_X] in 1 mL CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N) CEANOTHUS AMERICANUS LEAF 15 [hp_X] in 1 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 15 [hp_X] in 1 mL CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E) CHIONANTHUS VIRGINICUS BARK 15 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 15 [hp_X] in 1 mL DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA TUBER - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA TUBER 15 [hp_X] in 1 mL MUCUNA PRURIENS FRUIT TRICHOME (UNII: 3E271BSI0C) (MUCUNA PRURIENS FRUIT TRICHOME - UNII:3E271BSI0C) MUCUNA PRURIENS FRUIT TRICHOME 15 [hp_X] in 1 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 15 [hp_X] in 1 mL JUNIPER BERRY (UNII: O84B5194RL) (JUNIPER BERRY - UNII:O84B5194RL) JUNIPER BERRY 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL PTELEA TRIFOLIATA BARK (UNII: 5KQR6FTT0D) (PTELEA TRIFOLIATA BARK - UNII:5KQR6FTT0D) PTELEA TRIFOLIATA BARK 15 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 15 [hp_X] in 1 mL URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25) URIC ACID 15 [hp_X] in 1 mL SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE) SILYBUM MARIANUM SEED 15 [hp_X] in 1 mL CYNARA SCOLYMUS LEAF (UNII: B71UA545DE) (CYNARA SCOLYMUS LEAF - UNII:B71UA545DE) CYNARA SCOLYMUS LEAF 6 [hp_X] in 1 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69028-0002-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/04/2018 12/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/04/2018 12/31/2021 Labeler - Xymogen (791993389) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(69028-0002)