FDA.reportPublic FDA data

Acne - Cystic Acne

Manufacturer
Newton Laboratories, Inc | Newton Laboratories, Inc.
Effective date
2020-12-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:42

Label at a glance#

ProductAcne - Cystic Acne
Active ingredientCAUSTICUM, CHELIDONIUM MAJUS, SOLANUM DULCAMARA WHOLE, CALCIUM SULFIDE, CENTELLA ASIATICA, ECHINACEA, UNSPECIFIED, JUGLANS REGIA WHOLE, GOLD, TARAXACUM OFFICINALE, ANTIMONY TRISULFIDE, BERBERIS AQUIFOLIUM WHOLE, CALVATIA GIGANTEA WHOLE, POTASSIUM BROMIDE, ARCTIUM LAPPA WHOLE, ARSENIC TRIOXIDE, ACTIVATED CHARCOAL, GRAPHITE, ZINC, POTASSIUM IODIDE, LEDUM PALUSTRE WHOLE, SILICON DIOXIDE, SULFUR IODIDE, LYCOPODIUM CLAVATUM WHOLE, STRYCHNOS NUX-VOMICA WHOLE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times a day or as directed by a health professional.

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.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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
55714-4790-1Acne - Cystic Acne30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4790ACNE - CYSTIC ACNE (ECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEA) LIQUID [NEWTON LABORATORIES, INC]2Current NDC, Legacy NDC, 1 package rows20201203_92afe017-74c7-16c6-e053-2995a90a5c7d.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-479055714-4790-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAUSTICUMDD5FO1WKFUACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
JUGLANS REGIA WHOLE87EJ76IO83ACTIB
GOLD79Y1949PYOACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
TARAXACUM OFFICINALE39981FM375ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
BERBERIS AQUIFOLIUM WHOLEJ4WG1JVR05ACTIB
CALVATIA GIGANTEA WHOLEBR6B7CG29TACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
ARCTIUM LAPPA WHOLE73070DU1LAACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
GRAPHITE4QQN74LH4OACTIB
ZINCJ41CSQ7QDSACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
LEDUM PALUSTRE WHOLE1N8KG72C5MACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
LYCOPODIUM CLAVATUM WHOLE005ICF6L27ACTIB
STRYCHNOS NUX-VOMICA WHOLEAB2NX17POSACTIB

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
Acne - Cystic AcneECHINACEA, JUGLANS REGIA, LAPPA MAJOR, TARAXACUM OFFICINALE, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, AURUM METALLICUM, BERBERIS AQUIFOLIUM, BOVISTA, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, DULCAMARA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, LEDUM PALUSTRE, LYCOPDIUM CLAVATUM, NUX VOMICA, SULPHUR IODATUM, ZINCUM METALLICUM, SILICEANewton Laboratories, Inc92afe017-74c7-16c6-e053-2995a90a5c7d2020-12-02WarningsExact identifier
ndc (package): 55714-4790-1
ndc (product): 55714-4790
ndc11 (package): 55714479001
spl id: b57eb850-8be7-891c-e053-2995a90a5c46
spl set id: 92afe017-74c7-16c6-e053-2995a90a5c7d

Reported adverse events (FAERS/openFDA)#

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