Label: ROSACEA- arsenicum alb., arsenicum bromatum, carbo animalis, causticum, hydrocotyle, kali brom., kali iod., kreosotum, lycopodium, nux vom., petroleum, rhus toxicodendron, sepia, sulphur, echinacea, taraxacum pellet
-
Contains inactivated NDC Code(s)
NDC Code(s): 55714-2325-0, 55714-2325-1, 55714-2325-2 - 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 March 1, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
-
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
-
INGREDIENTS AND APPEARANCE
ROSACEA
arsenicum alb., arsenicum bromatum, carbo animalis, causticum, hydrocotyle, kali brom., kali iod., kreosotum, lycopodium, nux vom., petroleum, rhus toxicodendron, sepia, sulphur, echinacea, taraxacum pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2325 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 g Arsenic Tribromide (UNII: 41CN475O7F) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Tribromide 10 [hp_X] in 1 g Carbo Animalis (UNII: 279O8I0433) (Carbo Animalis - UNII:279O8I0433) Carbo Animalis 10 [hp_X] in 1 g Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum 10 [hp_X] in 1 g Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica 10 [hp_X] in 1 g Potassium Bromide (UNII: OSD78555ZM) (Bromide Ion - UNII:952902IX06) Potassium Bromide 10 [hp_X] in 1 g Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Iodide Ion 10 [hp_X] in 1 g Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote 10 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 g Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 10 [hp_X] in 1 g Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene 10 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 10 [hp_X] in 1 g Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice 10 [hp_X] in 1 g Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 10 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 g Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2325-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-2325-2 56.7 g in 1 BOTTLE, GLASS 3 NDC:55714-2325-0 7.08 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2325)