FDA.reportPublic FDA data

Acne

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:36

Label at a glance#

ProductAcne
Active ingredientANTIMONY TRISULFIDE, ARSENIC CATION (3+), 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

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

QUESTIONS

OTC - QUESTIONS SECTION

newtonlabs.net - Questions ? 800 448-7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 300123

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

OTC - PURPOSE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Juglans reg. 6x, Lappa 6x, Taraxacum 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Aur. met. 15x, Berber. aqui. 15x, Bovista 15x, Carbo veg. 15x, Causticum 15x, Chelidonium maj. 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.

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2385-1Acne28 g in 1 BOTTLE, GLASSPELLET282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2385ACNE (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) PELLET [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201125_798d5f34-819a-9895-e053-2991aa0a1d62.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-238555714-2385-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
ANTIMONY TRISULFIDEF79059A38UACTIB
ARSENIC CATION (3+)C96613F5AVACTIB
GOLD79Y1949PYOACTIB
MAHONIA AQUIFOLIUM ROOT BARKVZJ9F3C3SBACTIB
GIANT PUFFBALLI6839Y031AACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CAUSTICUMDD5FO1WKFUACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
GRAPHITE4QQN74LH4OACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIM
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
ZINCJ41CSQ7QDSACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ENGLISH WALNUT1V3SHR7QB7ACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcneANTIMON. 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, TARAXACUMNewton Laboratories, Inc.798d5f34-819a-9895-e053-2991aa0a1d622020-11-24WarningsExact identifier
ndc (package): 55714-2385-1
ndc (product): 55714-2385
ndc11 (package): 55714238501
spl id: b4ddcbcc-e895-1c05-e053-2995a90a63a0
spl set id: 798d5f34-819a-9895-e053-2991aa0a1d62

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.