FDA.reportPublic FDA data

Acne Vanishing Gel- 5%

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- 5%
Active ingredientBENZOYL PEROXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin, Propylene Glycol, Ethoxydigiycol, Laureth-7, Polyacrylamide C13-14 Isoparaffin, Potassium Sorbate, Triethanolamine, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol

OTC - PURPOSE SECTION

Acne Medication

INDICATIONS & USAGE SECTION

treats acne and helps prevent new acne blemishes from forming

kills acne bacteria

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Cleanse skin thoroughy 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 other day
  • If going outside, use a sunscreen

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

WARNINGS SECTION

WARNINGS: For External Use Only

OTHER SAFETY INFORMATION

Other Information

  • Store at room temperature
  • Keep tightly closed

OTC - DO NOT USE SECTION

Do not use

  • If you have very sensitive skin
  • If you are sensitive to benzoyl peroxide

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne Vanishing Gel 5% LabelAcne Vanishing Gel 5% Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN2
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD2
308694benzoyl peroxide 5 % Topical GelSY2

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
70367-002-012022-07-29C16284748780-1e4f33bdf-af69-d8a0-e053-dadaa90a6e4e72f6e761-d0c4-1a84-e053-2991aa0aad7c
70367-002-042022-07-29C16284748780-1e4f33bdf-af69-d8a0-e053-dadaa90a6e4e72f6e761-d0c4-1a84-e053-2991aa0aad7c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-002-01Acne Vanishing Gel- 5%30 mL in 1 TUBEGEL302
70367-002-04Acne Vanishing Gel- 5%120 mL in 1 TUBEGEL1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-002ACNE VANISHING GEL- 5% (BENZOYL PEROXIDE) GEL [ONLY YOURX, INC.]2Legacy NDC, 2 package rows20200124_72f6e761-d0c4-1a84-e053-2991aa0aad7c.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70367-00270367-002-01, 70367-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE)9Q5W5G6461IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
LAURETH-7Z95S6G8201IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MAGNESIUM DISODIUM EDTANDT563S5VZIACT

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
9cd56620-8bb5-1ff3-e053-2a95a90a6dbc72f6e761-d0c4-1a84-e053-2991aa0aad7c2020-01-23WarningsExact identifier
spl id: 9cd56620-8bb5-1ff3-e053-2a95a90a6dbc
spl set id: 72f6e761-d0c4-1a84-e053-2991aa0aad7c

Reported adverse events (FAERS/openFDA)#

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