FDA.reportPublic FDA data

Rosacea

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:54

Label at a glance#

ProductRosacea
Active ingredientECHINACEA, UNSPECIFIED, ARSENIC TRIOXIDE, ARSENIC TRIBROMIDE, CARBO ANIMALIS, CAUSTICUM, CENTELLA ASIATICA, POTASSIUM BROMIDE, POTASSIUM IODIDE, WOOD CREOSOTE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, KEROSENE, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, SULFUR, TARAXACUM OFFICINALE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as skin changes, discoloration and disomfort of the face, neck and scalp.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Taraxacum officinale 6x, Arsenicum album 15x, Arsenicum bromatum 15x, Carbo animalis 15x, Causticum 15x, Hydrocotyle asiatica 15x, Kali bromatum 15x, Kali iodatum 15x, Kreosotum 15x, Lycopodium clavatum 15x, Nux vomica 15x, Petroleum 15x, Rhus toxicodendron 15x, Sepia 15x, Sulphur 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as skin changes, discoloration and discomfort of the face, neck and scalp.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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

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.

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
55714-2510-1Rosacea30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2510ROSACEA (ECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHUR) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250212_9caca164-0e81-7ed3-e053-2995a90a1244.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-251055714-2510-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ARSENIC TRIBROMIDE41CN475O7FACTIB
CARBO ANIMALIS279O8I0433ACTIB
CAUSTICUMDD5FO1WKFUACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
POTASSIUM IODIDE1C4QK22F9JACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
KEROSENE1C89KKC04EACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
WATER059QF0KO0RIACT

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
RosaceaECHINACEA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE ASIATICA, KALI BROMATUM, KALI IODATUM, KREOSOTUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHURNewton Laboratories, Inc.9caca164-0e81-7ed3-e053-2995a90a12442025-02-10WarningsExact identifier
ndc (package): 55714-2510-1
ndc (product): 55714-2510
ndc11 (package): 55714251001
spl id: 2dcfec93-7cea-5464-e063-6294a90a9b77
spl set id: 9caca164-0e81-7ed3-e053-2995a90a1244

Reported adverse events (FAERS/openFDA)#

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