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 00:43:05

Label at a glance#

ProductOxy Total Care Vitamin C Serum
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

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

Dosage and administration

clean the skin thoroughly before applying this product use one to three drops to cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 da...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

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, only use one topical acne medication at a time.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product
  • use one to three drops to cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 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, ethoxydiglycol, butylene glycol, glycerin, disteareth-100 IPDI, 3-O-ethyl ascorbic acid [vitamin C], PEG-8 dimethicone, PEG-8 ricinoleate, citric acid, fragrance, ganoderma lucidum [mushroom] extract, hyaluronic acid, potassium sorbate, propanediol, silanetriol, sodium benzoate, xanthan gum

Questions?1-877-636-2677

MON-FRI 9AM-5PM (EST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OXY Total Care Vitamin Serum Image 01Image 01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN5
199308salicylic acid 5 MG/ML Topical SolutionSCD5
199308salicylic acid 0.5 % Topical SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-1315-12023-02-07C16284748780-1f386c649-b4e6-0266-e053-dadaa90a7c1aDrug Facts - OXY Total Care Vitamin C Serum
10742-1315-12023-01-30C16284748780-1f386c649-b4e6-0266-e053-dadaa90a7c1aDrug Facts - OXY Total Care Vitamin C Serum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-1315-1OxyTotal Care Vitamin C Serum37 mL in 1 VIAL, GLASSSOLUTION375
10742-1315-1OxyTotal Care Vitamin C Serum1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-1315OXY TOTAL CARE VITAMIN C SERUM (SALICYLIC ACID) SOLUTION [THE MENTHOLATUM COMPANY]5Current NDC, Legacy NDC, 2 package rows20241215_29b34faa-7c74-4e79-ad47-1660a3e701a7.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-131510742-1315-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
DISTEARETH-100 ISOPHORONE DIISOCYANATEP37PW4M0ISIACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT
PEG-8 DIMETHICONEGIA7T764ODIACT
PEG-8 RICINOLEATEDM36F4D2OUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
REISHITKD8LH0X2ZIACT
HYALURONIC ACIDS270N0TRQYIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
SILANETRIOLE52D0J3TS5IACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
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 Vitamin C SerumSALICYLIC ACIDThe Mentholatum Company29b34faa-7c74-4e79-ad47-1660a3e701a72024-12-13WarningsExact identifier
ndc (package): 10742-1315-1
ndc (product): 10742-1315
ndc11 (package): 10742131501
spl id: 292c302c-89e4-7e22-e063-6394a90ad940
spl set id: 29b34faa-7c74-4e79-ad47-1660a3e701a7

Reported adverse events (FAERS/openFDA)#

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