Rosacea

Manufacturer: Newton Laboratories, Inc.
Effective date: 2011-03-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:19

Label at a glance#

ProductRosacea

Active ingredientArsenic 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, Echinacea, Unspecified, Taraxacum Officinale

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb. 10x, Arsenicum bromatum 10x, Carbo animalis 10x, Causticum 10x, Hydrocotyle 10x, Kali brom. 10x, Kali iod. 10x, Kreosotum 10x, Lycopodium 10x, Nux vom. 10x, Petroleum 10x, Rhus toxicodendron 10x, Sepia 10x, Sulphur 10x, Echinacea 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

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

INACTIVE INGREDIENT SECTION

Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS SECTION

OTC - 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139	Product name	3	20240506
e5a77e9c-c528-733a-173d-914a234c024b	Product name	5	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-2325-0	2020-01-31	C162847	48780-1	9d75b9cf-d4e4-f424-e053-dadaa90a57ce	Rosacea
55714-2325-1	2020-01-31	C162847	48780-1	9d75b9cf-d4e4-f424-e053-dadaa90a57ce	Rosacea
55714-2325-2	2020-01-31	C162847	48780-1	9d75b9cf-d4e4-f424-e053-dadaa90a57ce	Rosacea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55714-2325-0	Rosacea	7.08 g in 1 BOTTLE, GLASS	PELLET	7.08	1
55714-2325-1	Rosacea	28.35 g in 1 BOTTLE, GLASS	PELLET	28.35	1
55714-2325-2	Rosacea	56.7 g in 1 BOTTLE, GLASS	PELLET	56.7	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2325	ROSACEA (ARSENICUM ALB., ARSENICUM BROMATUM, CARBO ANIMALIS, CAUSTICUM, HYDROCOTYLE, KALI BROM., KALI IOD., KREOSOTUM, LYCOPODIUM, NUX VOM., PETROLEUM, RHUS TOXICODENDRON, SEPIA, SULPHUR, ECHINACEA, TARAXACUM) PELLET [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 3 package rows	20131218_6d93f003-f431-53ab-89a5-4e51d0155fe9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arsenic Tribromide	ACTIVE INGREDIENT	41CN475O7F	1
Arsenic Trioxide	ACTIVE INGREDIENT	S7V92P67HO	1
Carbo Animalis	ACTIVE INGREDIENT	279O8I0433	1
Causticum	ACTIVE INGREDIENT	DD5FO1WKFU	1
Centella Asiatica	ACTIVE INGREDIENT	7M867G6T1U	1
Echinacea, Unspecified	ACTIVE INGREDIENT	4N9P6CC1DX	1
Kerosene	ACTIVE INGREDIENT	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE INGREDIENT	C88X29Y479	1
Potassium Bromide	ACTIVE INGREDIENT	OSD78555ZM	1
Potassium Iodide	ACTIVE INGREDIENT	1C4QK22F9J	1
Sepia Officinalis Juice	ACTIVE INGREDIENT	QDL83WN8C2	1
Strychnos Nux-vomica Seed	ACTIVE INGREDIENT	269XH13919	1
Sulfur	ACTIVE INGREDIENT	70FD1KFU70	1
Taraxacum Officinale	ACTIVE INGREDIENT	39981FM375	1
Toxicodendron Pubescens Leaf	ACTIVE INGREDIENT	6IO182RP7A	1
Wood Creosote	ACTIVE INGREDIENT	3JYG22FD73	1
Arsenic Cation (3+)	ACTIVE MOIETY	C96613F5AV	1
Bromide Ion	ACTIVE MOIETY	952902IX06	1
Carbo Animalis	ACTIVE MOIETY	279O8I0433	1
Causticum	ACTIVE MOIETY	DD5FO1WKFU	1
Centella Asiatica	ACTIVE MOIETY	7M867G6T1U	1
Echinacea, Unspecified	ACTIVE MOIETY	4N9P6CC1DX	1
Iodide Ion	ACTIVE MOIETY	09G4I6V86Q	1
Kerosene	ACTIVE MOIETY	1C89KKC04E	1
Lycopodium Clavatum Spore	ACTIVE MOIETY	C88X29Y479	1
Sepia Officinalis Juice	ACTIVE MOIETY	QDL83WN8C2	1
Strychnos Nux-vomica Seed	ACTIVE MOIETY	269XH13919	1
Sulfur	ACTIVE MOIETY	70FD1KFU70	1
Taraxacum Officinale	ACTIVE MOIETY	39981FM375	1
Toxicodendron Pubescens Leaf	ACTIVE MOIETY	6IO182RP7A	1
Wood Creosote	ACTIVE MOIETY	3JYG22FD73	1
Sucrose	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

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

Rosacea
Arsenicum alb., Arsenicum bromatum, Carbo animalis, Causticum, Hydrocotyle, Kali brom., Kali iod., Kreosotum, Lycopodium, Nux vom., Petroleum, Rhus toxicodendron, Sepia, Sulphur, Echinacea, Taraxacum
Arsenic Trioxide
Arsenic Cation (3+)
Arsenic Tribromide
Carbo Animalis
Causticum
Centella Asiatica
Potassium Bromide
Bromide Ion
Potassium Iodide
Iodide Ion
Wood Creosote
Lycopodium Clavatum Spore
Strychnos Nux-vomica Seed
Kerosene
Toxicodendron Pubescens Leaf
Sepia Officinalis Juice
Sulfur
Echinacea, Unspecified
Taraxacum Officinale
Sucrose

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2325	55714-2325-1, 55714-2325-2, 55714-2325-0

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
Name	UNII	Kind
Arsenic Trioxide	S7V92P67HO	ACTIB
Arsenic Tribromide	41CN475O7F	ACTIB
Carbo Animalis	279O8I0433	ACTIB
Causticum	DD5FO1WKFU	ACTIB
Centella Asiatica	7M867G6T1U	ACTIB
Potassium Bromide	OSD78555ZM	ACTIB
Potassium Iodide	1C4QK22F9J	ACTIM
Wood Creosote	3JYG22FD73	ACTIB
Lycopodium Clavatum Spore	C88X29Y479	ACTIB
Strychnos Nux-vomica Seed	269XH13919	ACTIB
Kerosene	1C89KKC04E	ACTIB
Toxicodendron Pubescens Leaf	6IO182RP7A	ACTIB
Sepia Officinalis Juice	QDL83WN8C2	ACTIB
Sulfur	70FD1KFU70	ACTIB
Echinacea, Unspecified	4N9P6CC1DX	ACTIB
Taraxacum Officinale	39981FM375	ACTIB
Sucrose	C151H8M554	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
Sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bd05daf9-d80e-8db1-55d1-1489b0ed25f3			6d93f003-f431-53ab-89a5-4e51d0155fe9	2011-03-01	Warnings	Exact identifier spl id: bd05daf9-d80e-8db1-55d1-1489b0ed25f3 spl set id: 6d93f003-f431-53ab-89a5-4e51d0155fe9

Reported adverse events (FAERS/openFDA)#

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