FDA.reportPublic FDA data

Oxy 10

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:06

Label at a glance#

ProductOxy 10 Tinted
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

treats and helps prevent acne

Dosage and administration

clean skin thoroughly before applying this product cover entire affected area with a thin layer 1 to 3 times daily 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

treats and helps prevent acne

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 this 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

  • clean skin thoroughly before applying this product
  • cover entire affected area with a thin layer 1 to 3 times daily
  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer, diethylhexyl sodium sulfosuccinate, edetate disodium, iron oxide, purified water, sodium hydroxide, talc, titanium dioxide

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxy 10 Tinted
Oxy 10 Tinted

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106310benzoyl peroxide 10 % Topical LotionPSN4
106310benzoyl peroxide 100 MG/ML Topical LotionSCD4
106310benzoyl peroxide 10 % Topical LotionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
10742-8354-12023-02-07C16284748780-1f386c649-c620-0266-e053-dadaa90a7c1aDrug Facts - Oxy 10 Tinted
10742-8354-12023-01-30C16284748780-1f386c649-c620-0266-e053-dadaa90a7c1aDrug Facts - Oxy 10 Tinted

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8354-1Oxy 10Tinted1 in 1 CARTONLOTION14
10742-8354-1Oxy 10Tinted30 g in 1 BOTTLELOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8354OXY 10 TINTED (BENZOYL PEROXIDE) LOTION [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241219_0ceee85d-dc8c-49b3-9b44-8fe60022c243.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM2
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA02
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6752
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
TALCINACTIVE INGREDIENT7SEV7J4R1U2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-835410742-8354-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
EDETATE DISODIUM7FLD91C86KIACT
FERRIC OXIDE RED1K09F3G675IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
4 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675LOTION / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
4 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
4 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0GEL / TOPICAL6 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ELOTION / TOPICAL300 mgExact identifier — unii+route+dosage form
2 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxy 10 TintedBENZOYL PEROXIDEThe Mentholatum Company0ceee85d-dc8c-49b3-9b44-8fe60022c2432024-12-17WarningsExact identifier
ndc (package): 10742-8354-1
ndc (product): 10742-8354
ndc11 (package): 10742835401
spl id: 2979a0e7-0983-237b-e063-6294a90add9d
spl set id: 0ceee85d-dc8c-49b3-9b44-8fe60022c243

Reported adverse events (FAERS/openFDA)#

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