Label: INCONTINENCE- aloe, arg. nit., arsenicum alb., belladonna, benzoicum acidum, bryonia, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, ignatia, kali phos., lycopodium, nat. mur., nitricum ac., plantago, pulsatilla, rhus aromatica , sabal, secale, sepia, staphysag.,stramonium, thyroidinum, verbascum, echinacea, hydrastis liquid
- NDC Code(s): 55714-4748-1
- Packager: Newton Laboratories, 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 December 3, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x,Aloe 15x, Argentum nitricum 15x, Arsenicum album 15x, Belladonna 15x, Benzoicum acidum 15x, Bryonia 15x, Cantharis 15x, Causticum 15x, Equisetum hyemale 15x, Ferrum metallicum 15x, Gelsemium sempervirens 15x, Ignatia amara 15x, Kali phosphoricum 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Nitricum acidum 15x, Plantago major 15x, Pulsatilla 15x, Rhus aromatica 15x, Sabal serrulata 15x, Secale cornutum 15x, Sepia 15x, Staphysagria 15x, Stramonium 15x, Thyroidinum 15x, Verbascum thapsus 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - 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
INCONTINENCE
aloe, arg. nit., arsenicum alb., belladonna, benzoicum acidum, bryonia, cantharis, causticum, equisetum hyemale, ferrum metallicum, gelsemium, ignatia, kali phos., lycopodium, nat. mur., nitricum ac., plantago, pulsatilla, rhus aromatica , sabal, secale, sepia, staphysag.,stramonium, thyroidinum, verbascum, echinacea, hydrastis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4748 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE 15 [hp_X] in 1 mL SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 15 [hp_X] in 1 mL BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID 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 CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 mL EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 15 [hp_X] in 1 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 15 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 15 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 15 [hp_X] in 1 mL POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 15 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 15 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 15 [hp_X] in 1 mL NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 15 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 15 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 15 [hp_X] in 1 mL RHUS AROMATICA ROOT BARK (UNII: Q3H36W0J42) (RHUS AROMATICA ROOT BARK - UNII:Q3H36W0J42) RHUS AROMATICA ROOT BARK 15 [hp_X] in 1 mL SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 15 [hp_X] in 1 mL CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N) CLAVICEPS PURPUREA SCLEROTIUM 15 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 15 [hp_X] in 1 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 15 [hp_X] in 1 mL DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3) DATURA STRAMONIUM 15 [hp_X] in 1 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 15 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 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:55714-4748-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-4748)