Label: ACNE - CYSTIC ACNE- echinacea, juglans regia, lappa major, taraxacum officinale, antimonium crudum, arsenicum album, aurum metallicum, berberis aquifolium, bovista, carbo vegetabilis, causticum, chelidonium majus, dulcamara, graphites, hepar sulphuris calcareum, hydrocotyle asiatica, kali bromatum, kali iodatum, ledum palustre, lycopdium clavatum, nux vomica, sulphur iodatum, zincum metallicum, silicea liquid
- NDC Code(s): 55714-4790-1
- 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 2, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Juglans reg. 6x, Lappa 6x, Taraxacum 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium maj. 15x, Dulcamara 15x, Graphites 15x, Hepar sulph. calc. 15x, Hydrocotyle 15x, Kali brom. 15x, Kali iod. 15x, Ledum 15x, Lycopodium 15x, Nux vom. 15x, Silicea 15x, Sulphur iod. 15x, Zinc. met. 15x.
- 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
ACNE - CYSTIC ACNE
echinacea, juglans regia, lappa major, taraxacum officinale, antimonium crudum, arsenicum album, aurum metallicum, berberis aquifolium, bovista, carbo vegetabilis, causticum, chelidonium majus, dulcamara, graphites, hepar sulphuris calcareum, hydrocotyle asiatica, kali bromatum, kali iodatum, ledum palustre, lycopdium clavatum, nux vomica, sulphur iodatum, zincum metallicum, silicea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4790 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 15 [hp_X] in 1 mL SOLANUM DULCAMARA WHOLE (UNII: G72JA9DHK5) (SOLANUM DULCAMARA WHOLE - UNII:G72JA9DHK5) SOLANUM DULCAMARA WHOLE 15 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 15 [hp_X] in 1 mL CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL JUGLANS REGIA WHOLE (UNII: 87EJ76IO83) (JUGLANS REGIA WHOLE - UNII:87EJ76IO83) JUGLANS REGIA WHOLE 6 [hp_X] in 1 mL GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD 15 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 6 [hp_X] in 1 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 15 [hp_X] in 1 mL BERBERIS AQUIFOLIUM WHOLE (UNII: J4WG1JVR05) (BERBERIS AQUIFOLIUM WHOLE - UNII:J4WG1JVR05) BERBERIS AQUIFOLIUM WHOLE 15 [hp_X] in 1 mL CALVATIA GIGANTEA WHOLE (UNII: BR6B7CG29T) (CALVATIA GIGANTEA WHOLE - UNII:BR6B7CG29T) CALVATIA GIGANTEA WHOLE 15 [hp_X] in 1 mL POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 15 [hp_X] in 1 mL ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA) (ARCTIUM LAPPA WHOLE - UNII:73070DU1LA) ARCTIUM LAPPA WHOLE 6 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 15 [hp_X] in 1 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 15 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 15 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 15 [hp_X] in 1 mL LEDUM PALUSTRE WHOLE (UNII: 1N8KG72C5M) (LEDUM PALUSTRE WHOLE - UNII:1N8KG72C5M) LEDUM PALUSTRE WHOLE 15 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 15 [hp_X] in 1 mL SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE 15 [hp_X] in 1 mL LYCOPODIUM CLAVATUM WHOLE (UNII: 005ICF6L27) (LYCOPODIUM CLAVATUM WHOLE - UNII:005ICF6L27) LYCOPODIUM CLAVATUM WHOLE 15 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA WHOLE (UNII: AB2NX17POS) (STRYCHNOS NUX-VOMICA WHOLE - UNII:AB2NX17POS) STRYCHNOS NUX-VOMICA WHOLE 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4790-1 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(55714-4790)
