FDA.reportPublic FDA data

OXY 3 in 1 Acne Pads

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 00:44:12

Label at a glance#

ProductOXY 3 in 1 Acne Pads
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

treats and helps prevent acne

Dosage and administration

use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily because too much drying of the skin may occur, start with 1 application, 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 Sensitivity test : Apply product sparingly to a small affected area fo...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Salicylic acid - Acne treatment

Uses

INDICATIONS & USAGE SECTION

treats and helps prevent acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • keep away from eyes, lips and mouth. If contact occurs, flush thoroughly with water.
  • 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.
  • do not leave pad on skin
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

  • use a pad to cleanse and cover the affected area with a thin layer of medicine 1 to 3 times daily
  • because too much drying of the skin may occur, start with 1 application, 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
  • Sensitivity test: Apply product sparingly to a small affected area for the first 3 days. If no discomfort occurs, follow directions above.

Other information

  • KEEP TIGHTLY CLOSED
  • avoid storing at temperatures above 100˚F (38˚C)
  • protect from freezing
  • keep away from flame, fire and heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (50% v/v), allantoin, capryloyl glycine, fragrance, isoceteth-20, jojoba wax PEG-120 esters, PEG-8/SMDI copolymer, phytic acid, purified water, trisodium EDTA, trolamine

Questions?

OTC - QUESTIONS SECTION

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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxy 3 in 1 Acne Pads
Oxy 3 in 1 Acne Pads

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797892salicylic acid 2 % Medicated PadPSN4
797892salicylic acid 20 MG/ML Medicated PadSCD4
797892salicylic acid 2 % Medicated PadSY4
797892salicylic acid 2 % Topical SwabSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-4359-12023-02-07C16284748780-1f386c64a-1882-0266-e053-dadaa90a7c1aDrug Facts
10742-4359-32023-02-07C16284748780-1f386c64a-1882-0266-e053-dadaa90a7c1aDrug Facts
10742-4359-12023-01-30C16284748780-1f386c64a-1882-0266-e053-dadaa90a7c1aDrug Facts
10742-4359-32023-01-30C16284748780-1f386c64a-1882-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-4359-1OXY 3 in 1 Acne Pads90 in 1 JARSWAB904
10742-4359-3OXY 3 in 1 Acne Pads115 in 1 JARSWAB1154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-4359OXY 3 IN 1 ACNE PADS (SALICYLIC ACID) SWAB [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 2 package rows20241219_5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-435910742-4359-1, 10742-4359-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALLANTOIN344S277G0ZIACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
ISOCETETH-20O020065R7ZIACT
ETHYL JOJOBATE2351QH8W1NIACT
PEG-8/SMDI COPOLYMERCCX72L6NY6IACT
FYTIC ACID7IGF0S7R8IIACT
WATER059QF0KO0RIACT
EDETATE TRISODIUM420IP921MBIACT
TROLAMINE9O3K93S3TKIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

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 3 in 1 Acne PadsSALICYLIC ACIDThe Mentholatum Company5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a2024-12-17WarningsExact identifier
ndc (package): 10742-4359-3
ndc (package): 10742-4359-1
ndc (product): 10742-4359
ndc11 (package): 10742435901
ndc11 (package): 10742435903
spl id: 2978a8c0-a77b-b39a-e063-6394a90ab5e2
spl set id: 5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a

Reported adverse events (FAERS/openFDA)#

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