Ultra Clear Treatment Lotion with salicylic and mandelic acid

Manufacturer
Ultraceuticals US LLC | Baxter Laboratories Pty. Ltd.
Effective date
2019-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:47

Label at a glance#

ProductUltra Clear Treatment
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Salicylic Acid 2% w/w Acne Treatment

OTC - PURPOSE SECTION

Uses

  • For treatment of acne
  • Helps clear acne blemishes and acne pimples

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water to remove.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor:

  • If skin irritation becomes severe

WARNINGS SECTION

Warnings

  • For external use only

When using this product

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Clean the skin thoroughly before applying this product. 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 dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultraceuticals

Ultra Clear Treatment Lotion

with Salicylic & Mandelic Acid

Acne Treatment Lotion

50mL / 1.69 fl OZ

Clear Treatment Lotion cartonClear Treatment Lotion carton.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103568salicylic acid 2 % Topical LotionPSN1
103568salicylic acid 20 MG/ML Topical LotionSCD1
103568salicylic acid 2 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73122-126-012021-01-29C16284748780-1ba0f9c33-3330-a910-e053-dadaa90a0b85Ultra Clear Treatment Lotion with salicylic and mandelic acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73122-126-01Ultra Clear Treatment50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73122-126ULTRA CLEAR TREATMENT (SALICYLIC ACID) LOTION [ULTRACEUTICALS US LLC]1Legacy NDC, 1 package rows20191015_937c3f0d-c42d-99aa-e053-2a95a90a0e66.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73122-12673122-126-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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
937c3f0d-c42e-99aa-e053-2a95a90a0e66937c3f0d-c42d-99aa-e053-2a95a90a0e662019-09-26WarningsExact identifier
spl id: 937c3f0d-c42e-99aa-e053-2a95a90a0e66
spl set id: 937c3f0d-c42d-99aa-e053-2a95a90a0e66

Reported adverse events (FAERS/openFDA)#

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