FDA.reportPublic FDA data

OXY

Manufacturer
The Mentholatum Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:11

Label at a glance#

ProductOXY Advanced Care Sensitive Skin Acne Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

for the treatment of acne clears acne pimples and allows skin to heal penetrates pores to control blackheads and whiteheads helps prevent new acne pimples from forming

Dosage and administration

wet face apply to hands then massage gently onto face rinse thoroughly and pat dry because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or s...

Storage and handling

THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS KEEP TIGHTLY CLOSED avoid storing at temperatures above 100°F (38°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • clears acne pimples and allows skin to heal
  • penetrates pores to control blackheads and whiteheads
  • helps prevent new acne pimples from forming

Warnings

WARNINGS SECTION

For external use only

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation becomes severe

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet face
  • apply to hands then massage gently onto face
  • rinse thoroughly and pat dry
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS
  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100°F (38°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, chlorphenesin, citric acid, glycerin, hydrolyzed soy protein, PEG-8 dimethicone, phenoxyethanol, portulaca oleracea extract, propanediol, rhodomyrtus tomentosa fruit extract, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

Questions?

OTC - QUESTIONS SECTION

1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube
Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN4
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD4
308696benzoyl peroxide 5 % Medicated Liquid SoapSY4

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
10742-1203-12023-02-07C16284748780-1f386c649-9a9b-0266-e053-dadaa90a7c1aDrug Facts - Advanced Care Sensitive Skin Acne Cleanser
10742-1203-22023-02-07C16284748780-1f386c649-9a9b-0266-e053-dadaa90a7c1aDrug Facts - Advanced Care Sensitive Skin Acne Cleanser
10742-1203-12023-01-30C16284748780-1f386c649-9a9b-0266-e053-dadaa90a7c1aDrug Facts - Advanced Care Sensitive Skin Acne Cleanser
10742-1203-22023-01-30C16284748780-1f386c649-9a9b-0266-e053-dadaa90a7c1aDrug Facts - Advanced Care Sensitive Skin Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1203-1OXYAdvanced Care Sensitive Skin Acne Cleanser148 mL in 1 TUBEGEL1484
10742-1203-2OXYAdvanced Care Sensitive Skin Acne Cleanser170 mL in 1 TUBEGEL1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1203OXY ADVANCED CARE SENSITIVE SKIN ACNE CLEANSER (BENZOYL PEROXIDE) GEL [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241215_4967f854-d1e4-4fb6-84c7-1293f5f90630.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-120310742-1203-1, 10742-1203-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DISODIUM LAURETH SULFOSUCCINATED6DH1DTN7EIACT
CAPRYL/CAPRAMIDOPROPYL BETAINE231H3ZT9NEIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHLORPHENESINI670DAL4SZIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
SOY PROTEINR44IWB3RN5IACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
PURSLANEM6S840WXG5IACT
PROPANEDIOL5965N8W85TIACT
RHODOMYRTUS TOMENTOSA FRUITQ99511S58KIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
OXY Advanced Care Sensitive Skin Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4967f854-d1e4-4fb6-84c7-1293f5f906302024-12-13WarningsExact identifier
ndc (package): 10742-1203-1
ndc (package): 10742-1203-2
ndc (product): 10742-1203
ndc11 (package): 10742120302
ndc11 (package): 10742120301
spl id: 292bf620-5cdd-388d-e063-6394a90a307c
spl set id: 4967f854-d1e4-4fb6-84c7-1293f5f90630

Reported adverse events (FAERS/openFDA)#

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