Acne Cystic Acne
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:03:44
Label at a glance#
ProductAcne Cystic Acne
Active ingredientAntimony Trisulfide, Arsenic Trioxide, Gold, Mahonia Aquifolium Root Bark, Giant Puffball, Activated Charcoal, Causticum, Chelidonium Majus, Solanum Dulcamara Top, Graphite, Calcium Sulfide, Centella Asiatica, Potassium Bromide, Potassium Iodide, Ledum Palustre Twig, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Silicon Dioxide, Sulfur Iodide, Zinc, Echinacea, Unspecified, English Walnut, Arctium Lappa Root, Taraxacum Officinale
Label structure10 sections
Contacts and useful links#
Websitewww.newtonlabs.net
www.newtonlabs.net
www.newtonlabs.netLabel contents#
Full prescribing information#
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.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4468-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9832-f424-e053-dadaa90a57ce | Acne~Cystic Acne |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4468-1 | Acne Cystic Acne | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4468 | 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 [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 1 package rows | 20120413_b556882e-e88a-94a1-6129-79b5545b693b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Activated Charcoal | ACTIVE INGREDIENT | 2P3VWU3H10 | 1 | |
| Antimony Trisulfide | ACTIVE INGREDIENT | F79059A38U | 1 | |
| Arctium Lappa Root | ACTIVE INGREDIENT | 597E9BI3Z3 | 1 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| Calcium Sulfide | ACTIVE INGREDIENT | 1MBW07J51Q | 1 | |
| Causticum | ACTIVE INGREDIENT | DD5FO1WKFU | 1 | |
| Centella Asiatica | ACTIVE INGREDIENT | 7M867G6T1U | 1 | |
| Chelidonium Majus | ACTIVE INGREDIENT | 7E889U5RNN | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| English Walnut | ACTIVE INGREDIENT | 1V3SHR7QB7 | 1 | |
| Giant Puffball | ACTIVE INGREDIENT | I6839Y031A | 1 | |
| Gold | ACTIVE INGREDIENT | 79Y1949PYO | 1 | |
| Graphite | ACTIVE INGREDIENT | 4QQN74LH4O | 1 | |
| Ledum Palustre Twig | ACTIVE INGREDIENT | 877L01IZ0P | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Mahonia Aquifolium Root Bark | ACTIVE INGREDIENT | VZJ9F3C3SB | 1 | |
| Potassium Bromide | ACTIVE INGREDIENT | OSD78555ZM | 1 | |
| Potassium Iodide | ACTIVE INGREDIENT | 1C4QK22F9J | 1 | |
| Silicon Dioxide | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Solanum Dulcamara Top | ACTIVE INGREDIENT | KPS1B1162N | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Sulfur Iodide | ACTIVE INGREDIENT | L6L8KA2AA0 | 1 | |
| Taraxacum Officinale | ACTIVE INGREDIENT | 39981FM375 | 1 | |
| Zinc | ACTIVE INGREDIENT | J41CSQ7QDS | 1 | |
| Activated Charcoal | ACTIVE MOIETY | 2P3VWU3H10 | 1 | |
| Antimony | ACTIVE MOIETY | 9IT35J3UV3 | 1 | |
| Arctium Lappa Root | ACTIVE MOIETY | 597E9BI3Z3 | 1 | |
| Arsenic Trioxide | ACTIVE MOIETY | S7V92P67HO | 1 | |
| Calcium Cation | ACTIVE MOIETY | 2M83C4R6ZB | 1 | |
| Causticum | ACTIVE MOIETY | DD5FO1WKFU | 1 | |
| Centella Asiatica | ACTIVE MOIETY | 7M867G6T1U | 1 | |
| Chelidonium Majus | ACTIVE MOIETY | 7E889U5RNN | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| English Walnut | ACTIVE MOIETY | 1V3SHR7QB7 | 1 | |
| Giant Puffball | ACTIVE MOIETY | I6839Y031A | 1 | |
| Gold | ACTIVE MOIETY | 79Y1949PYO | 1 | |
| Graphite | ACTIVE MOIETY | 4QQN74LH4O | 1 | |
| Ledum Palustre Twig | ACTIVE MOIETY | 877L01IZ0P | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Mahonia Aquifolium Root Bark | ACTIVE MOIETY | VZJ9F3C3SB | 1 | |
| Potassium Cation | ACTIVE MOIETY | 295O53K152 | 1 | |
| Silicon Dioxide | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| Solanum Dulcamara Top | ACTIVE MOIETY | KPS1B1162N | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Sulfur Iodide | ACTIVE MOIETY | L6L8KA2AA0 | 1 | |
| Taraxacum Officinale | ACTIVE MOIETY | 39981FM375 | 1 | |
| Zinc | ACTIVE MOIETY | J41CSQ7QDS | 1 |
Products#
Every source-derived product name is available through these pages.
- 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
- Antimony Trisulfide
- Antimony
- Arsenic Trioxide
- Gold
- Mahonia Aquifolium Root Bark
- Giant Puffball
- Activated Charcoal
- Causticum
- Chelidonium Majus
- Solanum Dulcamara Top
- Graphite
- Calcium Sulfide
- Calcium Cation
- Centella Asiatica
- Potassium Bromide
- Potassium Cation
- Potassium Iodide
- Ledum Palustre Twig
- Lycopodium Clavatum Spore
- Strychnos Nux-vomica Seed
- Silicon Dioxide
- Sulfur Iodide
- Zinc
- Echinacea, Unspecified
- English Walnut
- Arctium Lappa Root
- Taraxacum Officinale
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4468 | 55714-4468-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 236b7f55-1e7d-1bdf-e986-e6ca9084b694 | b556882e-e88a-94a1-6129-79b5545b693b | 2011-06-01 | Warnings | 236b7f55-1e7d-1bdf-e986-e6ca9084b694 b556882e-e88a-94a1-6129-79b5545b693b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.