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

Acne Cystic Acne by

Drug Labeling and Warnings

Acne Cystic Acne by is a Homeopathic medication manufactured, distributed, or labeled by Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 55714-4468
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Antimony Trisulfide (UNII: F79059A38U) (Antimony - UNII:9IT35J3UV3)	Antimony Trisulfide	15 [hp_X]  in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Trioxide - UNII:S7V92P67HO)	Arsenic Trioxide	15 [hp_X]  in 1 mL
Gold (UNII: 79Y1949PYO) (Gold - UNII:79Y1949PYO)	Gold	15 [hp_X]  in 1 mL
Mahonia Aquifolium Root Bark (UNII: VZJ9F3C3SB) (Mahonia Aquifolium Root Bark - UNII:VZJ9F3C3SB)	Mahonia Aquifolium Root Bark	15 [hp_X]  in 1 mL
Giant Puffball (UNII: I6839Y031A) (Giant Puffball - UNII:I6839Y031A)	Giant Puffball	15 [hp_X]  in 1 mL
Activated Charcoal (UNII: 2P3VWU3H10) (Activated Charcoal - UNII:2P3VWU3H10)	Activated Charcoal	15 [hp_X]  in 1 mL
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 Top (UNII: KPS1B1162N) (Solanum Dulcamara Top - UNII:KPS1B1162N)	Solanum Dulcamara Top	15 [hp_X]  in 1 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	15 [hp_X]  in 1 mL
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Sulfide	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) (Potassium Cation - UNII:295O53K152)	Potassium Bromide	15 [hp_X]  in 1 mL
Potassium Iodide (UNII: 1C4QK22F9J) (Potassium Cation - UNII:295O53K152)	Potassium Iodide	15 [hp_X]  in 1 mL
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P)	Ledum Palustre Twig	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
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
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	15 [hp_X]  in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X]  in 1 mL
English Walnut (UNII: 1V3SHR7QB7) (English Walnut - UNII:1V3SHR7QB7)	English Walnut	3 [hp_X]  in 1 mL
Arctium Lappa Root (UNII: 597E9BI3Z3) (Arctium Lappa Root - UNII:597E9BI3Z3)	Arctium Lappa Root	3 [hp_X]  in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375)	Taraxacum Officinale	3 [hp_X]  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55714-4468-1	29.57 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/01/2011

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	MANUFACTURE, API MANUFACTURE