Label: RENEW- sanicula, abrotanum, argentum nitricum, arsenicum album, baryta carbonica, borax, bryonia, cactus grandiflorus, calcarea fluorica, calcarea phosphorica, calcarea sulphurica, chelidonium majus, cholesterinum, coffea cruda, conium maculatum, dulcamara, ferrum phosphoricum, fumaria officinalis, gratiola officinalis, helleborus niger, hepar sulphuris calcareum, hydrastis canadensis, hydrofluoricum acidum, iodium, kali carbonicum, kali muriaticum, kali phosphoricum, kali sulphuricum, lilium tigrinum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 24165-0001-1, 24165-0001-2 - Packager: Anila, 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 April 15, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Sanicula 15x, Abrotanum 10x, Arg. nit. 10x, Arsenicum alb. 10x, Baryta carb. 10x, Borax 10x, Bryonia 10x, Cactus 10x, Calc. fluor. 10x, Calc. phos. 10x, Calc. sulph. 10x, Chelidonium maj. 10x, Cholesterinum 10x, Coffea cruda 10x, Conium 10x, Dulcamara 10x, Ferrum phos. 10x, Fumaria 10x, Gratiola 10x, Hellebor. nig. 10x, Hepar sulph. calc. 10x, Hydrastis 10x, Hydrofluoricum ac. 10x, Iodium 10x, Kali carb. 10x, Kali mur. 10x, Kali phos. 10x, Kali sulph. 10x, Lilium 10x, Lycopodium 10x, Mag. mur. 10x, Mag. phos. 10x, Nat. mur.10x, Nat.phos. 10x, Nat. sulph. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Sarsaparilla 10x, Secale 10x, Selenium 10x, Sepia 10x, Silicea 10x, Spigelia anth. 10x, Sulphur 10x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
RENEW
sanicula, abrotanum, argentum nitricum, arsenicum album, baryta carbonica, borax, bryonia, cactus grandiflorus, calcarea fluorica, calcarea phosphorica, calcarea sulphurica, chelidonium majus, cholesterinum, coffea cruda, conium maculatum, dulcamara, ferrum phosphoricum, fumaria officinalis, gratiola officinalis, helleborus niger, hepar sulphuris calcareum, hydrastis canadensis, hydrofluoricum acidum, iodium, kali carbonicum, kali muriaticum, kali phosphoricum, kali sulphuricum, lilium tigrinum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24165-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Chloride 15 [hp_X] in 1 mL Calcium Bicarbonate (UNII: 7PRA4BLM2L) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Bicarbonate 15 [hp_X] in 1 mL Potassium Sulfate (UNII: 1K573LC5TV) (Sulfate Ion - UNII:7IS9N8KPMG) Potassium Sulfate 15 [hp_X] in 1 mL Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation - UNII:LYR4M0NH37) Sodium Bicarbonate 15 [hp_X] in 1 mL Artemisia Abrotanum Flowering Top (UNII: QG07G580U0) (Artemisia Abrotanum Flowering Top - UNII:QG07G580U0) Artemisia Abrotanum Flowering Top 10 [hp_X] in 1 mL Silver Nitrate (UNII: 95IT3W8JZE) (Silver Cation - UNII:57N7B0K90A) Silver Nitrate 10 [hp_X] in 1 mL Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Cation (3+) 10 [hp_X] in 1 mL Barium Carbonate (UNII: 6P669D8HQ8) (Barium Cation - UNII:V645272HLN) Barium Cation 10 [hp_X] in 1 mL Sodium Borate (UNII: 91MBZ8H3QO) (Borate Ion - UNII:44OAE30D22) Sodium Borate 10 [hp_X] in 1 mL Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 mL Selenicereus Grandiflorus Stem (UNII: 7114SV0MYK) (Selenicereus Grandiflorus Stem - UNII:7114SV0MYK) Selenicereus Grandiflorus Stem 10 [hp_X] in 1 mL Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 10 [hp_X] in 1 mL Tribasic Calcium Phosphate (UNII: 91D9GV0Z28) (Phosphate Ion - UNII:NK08V8K8HR) Tribasic Calcium Phosphate 10 [hp_X] in 1 mL Calcium Sulfate Anhydrous (UNII: E934B3V59H) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation 10 [hp_X] in 1 mL Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus 10 [hp_X] in 1 mL Cholesterol (UNII: 97C5T2UQ7J) (Cholesterol - UNII:97C5T2UQ7J) Cholesterol 10 [hp_X] in 1 mL Arabica Coffee Bean (UNII: 3SW678MX72) (Arabica Coffee Bean - UNII:3SW678MX72) Arabica Coffee Bean 10 [hp_X] in 1 mL Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top 10 [hp_X] in 1 mL Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top 10 [hp_X] in 1 mL Ferrosoferric Phosphate (UNII: 91GQH8I5F7) (Ferrosoferric Phosphate - UNII:91GQH8I5F7) Ferrosoferric Phosphate 10 [hp_X] in 1 mL Hydrofluoric Acid (UNII: RGL5YE86CZ) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 10 [hp_X] in 1 mL Fumaria Officinalis Flowering Top (UNII: VH659J61ZL) (Fumaria Officinalis Flowering Top - UNII:VH659J61ZL) Fumaria Officinalis Flowering Top 10 [hp_X] in 1 mL Gratiola Officinalis (UNII: BDD9991A36) (Gratiola Officinalis - UNII:BDD9991A36) Gratiola Officinalis 10 [hp_X] in 1 mL Helleborus Niger Root (UNII: 608DGJ6815) (Helleborus Niger Root - UNII:608DGJ6815) Helleborus Niger Root 10 [hp_X] in 1 mL Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 10 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 10 [hp_X] in 1 mL Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 10 [hp_X] in 1 mL Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate 10 [hp_X] in 1 mL Potassium Chloride (UNII: 660YQ98I10) (Chloride Ion - UNII:Q32ZN48698) Potassium Chloride 10 [hp_X] in 1 mL Potassium Phosphate, Dibasic (UNII: CI71S98N1Z) (Phosphate Ion - UNII:NK08V8K8HR) Potassium Phosphate, Dibasic 10 [hp_X] in 1 mL Lilium Lancifolium Whole Flowering (UNII: X67Z2963PI) (Lilium Lancifolium Whole Flowering - UNII:X67Z2963PI) Lilium Lancifolium Whole Flowering 10 [hp_X] in 1 mL Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 mL Magnesium Chloride (UNII: 02F3473H9O) (Chloride Ion - UNII:Q32ZN48698) Magnesium Chloride 10 [hp_X] in 1 mL Magnesium Phosphate, Dibasic Trihydrate (UNII: HF539G9L3Q) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Phosphate, Dibasic Trihydrate 10 [hp_X] in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 10 [hp_X] in 1 mL Sodium Phosphate, Dibasic, Heptahydrate (UNII: 70WT22SF4B) (Phosphate Ion - UNII:NK08V8K8HR) Sodium Phosphate, Dibasic, Heptahydrate 10 [hp_X] in 1 mL Sodium Sulfate (UNII: 0YPR65R21J) (Sodium Sulfate Anhydrous - UNII:36KCS0R750) Sodium Sulfate 10 [hp_X] in 1 mL Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 1 mL Podophyllum (UNII: 2S713A4VP3) (Podophyllum - UNII:2S713A4VP3) Podophyllum 10 [hp_X] in 1 mL Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 mL Smilax Regelii Root (UNII: 2H1576D5WG) (Smilax Regelii Root - UNII:2H1576D5WG) Smilax Regelii Root 10 [hp_X] in 1 mL Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium 10 [hp_X] in 1 mL Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium 10 [hp_X] in 1 mL Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X] in 1 mL Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide 10 [hp_X] in 1 mL Spigelia Anthelmia (UNII: WYT05213GE) (Spigelia Anthelmia - UNII:WYT05213GE) Spigelia Anthelmia 10 [hp_X] in 1 mL Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 10 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24165-0001-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:24165-0001-2 59.14 mL in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/15/2014 Labeler - Anila, Inc. (962309543) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(24165-0001)
