FDA.reportPublic FDA data

Rosacea

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:44:14

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 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 - 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2511-12025-10-03C16284748780-1d6a99b39-ed63-a426-e053-dadaa90af4c2Rosacea 2511P
55714-2511-12022-01-28C16284748780-1d6a99b39-ed63-a426-e053-dadaa90af4c2Rosacea 2511P

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2511ROSACEA (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) PELLET [NEWTON LABORATORIES, INC.]1Legacy NDC20200122_9caee00b-252f-9ab2-e053-2a95a90a3cac.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-251155714-2511-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
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

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
4044255d-35c1-1a4b-e063-6294a90a1e2f9caee00b-252f-9ab2-e053-2a95a90a3cac2025-10-03WarningsExact identifier
spl set id: 9caee00b-252f-9ab2-e053-2a95a90a3cac

Reported adverse events (FAERS/openFDA)#

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