Label: ACNE CYSTIC ACNE- antimon. crud., arsenicum alb., aur. met., berber. aqui., bovista, carbo veg., causticum, chelidonium majus, dulcamara, graphites, hepar sulph. calc., hydrocotyle, kali brom., kali iod., ledum, lycopodium, nux vom., silicea, sulphur iod., zinc. met., echinacea, juglans regia, lappa, taraxacum liquid

  • Category: HUMAN PRESCRIPTION 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 June 1, 2011

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  • PRODUCT NAME & INDICATIONS SECTION

    ACNE~CYSTIC ACNE  Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.      

  • DIRECTION SECTION

    Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.              

  • ACTIVE INGREDIENT SECTION

    Antimon. crud. 15x, Arsenicum alb.5x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium majus 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, Echinacea 3x, Juglans regia 3x, Lappa 3x, Taraxacum 3x.      

  • PURPOSE SECTION

    Formulated for symptoms associated with acne and other skin conditions such as boils, pimples, pustules and sebaceous cysts.

  • INACTIVE INGREDIENT SECTION

    Inactive Ingredients: 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. 

  • PREGNANCY OR BREAST FEEDING SECTION

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

  • KEEP OUT OF REACH OF CHILDREN SECTION

    Keep out of reach of children.        

  • PACKAGE LABEL.

    Package label

  • INGREDIENTS AND APPEARANCE
    ACNE CYSTIC ACNE  
    antimon. crud., arsenicum alb., aur. met., berber. aqui., bovista, carbo veg., causticum, chelidonium majus, dulcamara, graphites, hepar sulph. calc., hydrocotyle, kali brom., kali iod., ledum, lycopodium, nux vom., silicea, sulphur iod., zinc. met., echinacea, juglans regia, lappa, taraxacum liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4468
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Antimony Trisulfide (UNII: F79059A38U) (Antimony - UNII:9IT35J3UV3) Antimony Trisulfide15 [hp_X]  in 1 mL
    Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Trioxide - UNII:S7V92P67HO) Arsenic Trioxide15 [hp_X]  in 1 mL
    Gold (UNII: 79Y1949PYO) (Gold - UNII:79Y1949PYO) Gold15 [hp_X]  in 1 mL
    Mahonia Aquifolium Root Bark (UNII: VZJ9F3C3SB) (Mahonia Aquifolium Root Bark - UNII:VZJ9F3C3SB) Mahonia Aquifolium Root Bark15 [hp_X]  in 1 mL
    Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A) Giant Puffball15 [hp_X]  in 1 mL
    Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10) Activated Charcoal15 [hp_X]  in 1 mL
    Causticum (UNII: DD5FO1WKFU) (Causticum - UNII:DD5FO1WKFU) Causticum15 [hp_X]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus15 [hp_X]  in 1 mL
    Solanum Dulcamara Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N) Solanum Dulcamara Top15 [hp_X]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite15 [hp_X]  in 1 mL
    Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Sulfide15 [hp_X]  in 1 mL
    Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica15 [hp_X]  in 1 mL
    Potassium Bromide (UNII: OSD78555ZM) (Potassium Cation - UNII:295O53K152) Potassium Bromide15 [hp_X]  in 1 mL
    Potassium Iodide (UNII: 1C4QK22F9J) (Potassium Cation - UNII:295O53K152) Potassium Iodide15 [hp_X]  in 1 mL
    Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig15 [hp_X]  in 1 mL
    Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
    Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide15 [hp_X]  in 1 mL
    Sulfur Iodide (UNII: L6L8KA2AA0) (Sulfur Iodide - UNII:L6L8KA2AA0) Sulfur Iodide15 [hp_X]  in 1 mL
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 [hp_X]  in 1 mL
    Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [hp_X]  in 1 mL
    English Walnut (UNII: 1V3SHR7QB7) (English Walnut - UNII:1V3SHR7QB7) English Walnut3 [hp_X]  in 1 mL
    Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3) Arctium Lappa Root3 [hp_X]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale3 [hp_X]  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55714-4468-129.57 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/2011
    Labeler - Newton Laboratories, Inc. (788793610)
    Registrant - Newton Laboratories, Inc. (788793610)
    Establishment
    NameAddressID/FEIBusiness Operations
    Newton Laboratories, Inc.788793610MANUFACTURE, API MANUFACTURE
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