FDA.reportPublic FDA data

Oxy

Manufacturer
The Mentholatum Company
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:43:28

Label at a glance#

ProductOxy Total Care Creamy Facial Cleanser
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne. Helps prevent new acne blemishes.

Dosage and administration

wet face dispense one to two pumps into your palm gently massage cleanser onto skin, avoiding eye area rinse thoroughly use one to two times daily Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Salicylic acid – Acne treatment

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.

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Helps prevent new acne blemishes.

Warnings

WARNINGS SECTION

For external use only.

When using this product

  • keep away from eyes. 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, use only one topical acne medication at a time.

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet face
  • dispense one to two pumps into your palm
  • gently massage cleanser onto skin, avoiding eye area
  • rinse thoroughly
  • use one to two times daily
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, sodium C14-16 olefin sulfonate, disodium cocoamphodiacetate, methyl gluceth-20, sodium cocoyl isethionate, disodium EDTA, fragrance, hydroxypropyltrimonium hyaluronate, PEG-7 glyceryl cocoate, PEG-8 dimethicone, potassium sorbate, sodium benzoate, triethanolamone

Questions?1-877-636-2677

MON-FRI 9AM-5PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Oxy Total Care Creamy Facial Cleanser
Oxy Total Care Creamy Facial Cleanser
Drug Facts
Drug Facts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN5
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD5
562600salicylic acid 2 % Facial Cleanser TonerSY5
562600salicylic acid 2 % Facial ScrubSY5
562600salicylic acid 2 % Medicated Liquid SoapSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1316-12023-02-07C16284748780-1f386c649-ec68-0266-e053-dadaa90a7c1aDrug Facts - OXY Total Care Creamy Facial Cleanser
10742-1316-12023-01-30C16284748780-1f386c649-ec68-0266-e053-dadaa90a7c1aDrug Facts - OXY Total Care Creamy Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1316-1OxyTotal Care Creamy Facial Cleanser148 mL in 1 TUBECREAM1485

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1316OXY TOTAL CARE CREAMY FACIAL CLEANSER (SALICYLIC ACID) CREAM [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 1 package rows20241215_aed37bff-6723-4865-aa9b-10e7adcceeea.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-131610742-1316-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
METHYL GLUCETH-20J3QD0LD11PIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
EDETATE DISODIUM7FLD91C86KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PEG-8 DIMETHICONEGIA7T764ODIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
TROLAMINE9O3K93S3TKIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 Total Care Creamy Facial CleanserSALICYLIC ACIDThe Mentholatum Companyaed37bff-6723-4865-aa9b-10e7adcceeea2024-12-13WarningsExact identifier
ndc (package): 10742-1316-1
ndc (product): 10742-1316
ndc11 (package): 10742131601
spl id: 292c36d3-d313-86dd-e063-6394a90a7c80
spl set id: aed37bff-6723-4865-aa9b-10e7adcceeea

Reported adverse events (FAERS/openFDA)#

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