Acne Vanishing Gel- 10% with Sulfur

Manufacturer
Only Yourx, Inc.
Effective date
2020-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:24

Label at a glance#

ProductAcne Vanishing Gel- 10% with Sulfur
Active ingredientBENZOYL PEROXIDE, SULFUR
Label structure12 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

WARNINGS: For External Use Only

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Benzoyl Peroxide 10%

Sulfur 3%

INDICATIONS & USAGE SECTION

Treats acne and helps prevent new blemishes from forming

Kills acne bacteria

OTC - DO NOT USE SECTION

Do Not Use: if you have very sensitive skin

are sensitive to benzoyl peroxide or sulfur

OTC - WHEN USING SECTION

When using this product

avoid sun exposure and use sunscreen

using other acne medications at the same time may cause excessive dryness or irritation of the skin

may bleach hair and fabrics

do not use in or near eyes, lips and mouth

OTC - ASK DOCTOR SECTION

Consult a doctor if excessive irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

DOSAGE & ADMINISTRATION SECTION

Directions:

cleanse skin thoroughly before applying

cover entire affected area with thin layer 1 to 3 times daily

if excessive dryness or irritation occurs, reduce application to once a day or every oter day
if going outside, use a sunscreen

OTHER SAFETY INFORMATION

Other information

store at room temperature

keep tightly closed

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water, Ethoxydiglycol, Cetyl Octanoate, Glyceryl Stearate, APEG-100 Stearate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Ceteareth-20, Polyacrylamide C13-14 Isoparaffin, Laureth-7, Dimethicone, Potassium Sorbate, Polysorbate 20, Acrylates C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Triethanolamine, Ethylhexylglycerin, Phenoxyethanol

OTC - PURPOSE SECTION

To treat acne and reduce inflammation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Vanishing Gel- 10% with SulfurAcne Vanishing Gel- 10% with Sulfur

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70367-003-012022-07-29C16284748780-1e4f33bdf-a300-d8a0-e053-dadaa90a6e4e270814fa-0107-6262-e054-00144ff8d46c
70367-003-042022-07-29C16284748780-1e4f33bdf-a300-d8a0-e053-dadaa90a6e4e270814fa-0107-6262-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-003-01Acne Vanishing Gel- 10% with Sulfur30 mL in 1 TUBEGEL302
70367-003-04Acne Vanishing Gel- 10% with Sulfur120 mL in 1 TUBEGEL1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-003ACNE VANISHING GEL- 10% WITH SULFUR (BENZOYL PEROXIDE, SULFUR) GEL [ONLY YOURX, INC.]2Legacy NDC, 2 package rows20200124_270814fa-0107-6262-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70367-00370367-003-01, 70367-003-04

Ingredients#

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

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

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
9cd58dcd-38fd-93a8-e053-2995a90a4c7d270814fa-0107-6262-e054-00144ff8d46c2020-01-23WarningsExact identifier
spl id: 9cd58dcd-38fd-93a8-e053-2995a90a4c7d
spl set id: 270814fa-0107-6262-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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