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 liquid

  • 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

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  • INDICATIONS & USAGE SECTION

    Rosacea  Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

  • DOSAGE & ADMINISTRATION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

  • OTC - ACTIVE INGREDIENT SECTION

    Arsenicum alb. 10x, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 3x, Taraxacum 3x.

  • OTC - PURPOSE SECTION

    Formulated for associated symptoms such as skin changes, discoloration and discomfort of the skin on the face, neck and scalp.

  • INACTIVE INGREDIENT SECTION

    USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.  

  • QUESTIONS SECTION

    www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
    Questions?  1.800.448.7256

  • WARNINGS SECTION

    Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.

  • PACKAGE LABEL

    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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2324
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 mL
    Arsenic Tribromide (UNII: 41CN475O7F) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Tribromide10 [hp_X]  in 1 mL
    Carbo Animalis (UNII: 279O8I0433) (Carbo Animalis - UNII:279O8I0433) Carbo Animalis10 [hp_X]  in 1 mL
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum10 [hp_X]  in 1 mL
    Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica10 [hp_X]  in 1 mL
    Potassium Bromide (UNII: OSD78555ZM) (Potassium Cation - UNII:295O53K152) Potassium Bromide10 [hp_X]  in 1 mL
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide10 [hp_X]  in 1 mL
    Wood Creosote (UNII: 3JYG22FD73) (Wood Creosote - UNII:3JYG22FD73) Wood Creosote10 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 mL
    Kerosene (UNII: 1C89KKC04E) (Kerosene - UNII:1C89KKC04E) Kerosene10 [hp_X]  in 1 mL
    Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf10 [hp_X]  in 1 mL
    Sepia Officinalis Juice (UNII: QDL83WN8C2) (Sepia Officinalis Juice - UNII:QDL83WN8C2) Sepia Officinalis Juice10 [hp_X]  in 1 mL
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur10 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-2324-129.57 mL in 1 BOTTLE, GLASS
    2NDC:55714-2324-259.14 mL in 1 BOTTLE, GLASS
    3NDC:55714-2324-0.5 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE(55714-2324)
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