Label: ROSACEA- echinacea, taraxacum officinale, arsenicum album, arsenicum bromatum, carbo animalis, causticum, hydrocotyle asiatica, kali bromatum, kali iodatum, kreosotum, lycopodium clavatum, nux vomica, petroleum, rhus toxicodendron, sepia, sulphur liquid
- NDC Code(s): 55714-2510-1
- Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 21, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
-
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Taraxacum officinale 6x, Arsenicum album 15x, Arsenicum bromatum 15x, Carbo animalis 15x, Causticum 15x, Hydrocotyle asiatica 15x, Kali bromatum 15x, Kali iodatum 15x, Kreosotum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Petroleum 15x, Rhus toxicodendron 15x, Sepia 15x, Sulphur 15x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- WARNINGS SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
-
INGREDIENTS AND APPEARANCE
ROSACEA
echinacea, taraxacum officinale, arsenicum album, arsenicum bromatum, carbo animalis, causticum, hydrocotyle asiatica, kali bromatum, kali iodatum, kreosotum, lycopodium clavatum, nux vomica, petroleum, rhus toxicodendron, sepia, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2510 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL ARSENIC TRIBROMIDE (UNII: 41CN475O7F) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIBROMIDE 15 [hp_X] in 1 mL CARBO ANIMALIS (UNII: 279O8I0433) (CARBO ANIMALIS - UNII:279O8I0433) CARBO ANIMALIS 15 [hp_X] in 1 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 15 [hp_X] in 1 mL CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 15 [hp_X] in 1 mL POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE 15 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 15 [hp_X] in 1 mL WOOD CREOSOTE (UNII: 3JYG22FD73) (WOOD CREOSOTE - UNII:3JYG22FD73) WOOD CREOSOTE 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 STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 15 [hp_X] in 1 mL KEROSENE (UNII: 1C89KKC04E) (KEROSENE - UNII:1C89KKC04E) KEROSENE 15 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 15 [hp_X] in 1 mL TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 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:55714-2510-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2510)