cream

Manufacturer
Oxygen Development LLC
Effective date
2023-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:22

Label at a glance#

Productcream
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming

Dosage and administration

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer morning and night for best results. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming

Warnings

WARNINGS SECTION

For external use only

When using use only

OTC - WHEN USING SECTION

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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 the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer morning and night for best results.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

OTHER SAFETY INFORMATION

Store at 20 - 25C (68-77F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-099_aw61354-099_aw

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-099-01_aw61354-099-01_aw

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
422997salicylic acid 1.5 % Topical LotionPSN1
422997salicylic acid 15 MG/ML Topical LotionSCD1
422997salicylic acid 1.5 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-099-012025-01-30C16284748780-12cef2736-74fb-d83d-e063-dadaa90ab31fACNE SERUM Medicated Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-099-01cream1 in 1 CARTONLOTION11
61354-099-01cream100 mg in 1 BOTTLE, PUMPLOTION1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-099CREAM (SALICYLIC ACID) LOTION [OXYGEN DEVELOPMENT LLC]12 package rows20230627_ff0b2dc9-c371-4bb6-e053-6394a90aefad.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-09961354-099-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
ff0b2dc9-c372-4bb6-e053-6394a90aefadff0b2dc9-c371-4bb6-e053-6394a90aefad2023-06-26WarningsExact identifier
spl id: ff0b2dc9-c372-4bb6-e053-6394a90aefad
spl set id: ff0b2dc9-c371-4bb6-e053-6394a90aefad

Reported adverse events (FAERS/openFDA)#

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