Clearcalm Non-Drying Acne Treatment Gel

Manufacturer
Ren Ltd.
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:46

Label at a glance#

ProductClearcalm Non-Drying Acne Treatment
Active ingredientSALICYLIC ACID
Label structure6 sections

Dosage and administration

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 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 0.5%

Purpose

OTC - PURPOSE SECTION

AcneTreatment

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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.

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 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol Denat.,Glycerin, Xanthan Gum, Maritime Pine Bark Extract, Caprylyl/Capryl Glucoside, Willow Bark Extract, Xylitylglucoside, Anhydroxylitol, Sodium Benzoate, Xylitol, Propanediol, Sandalwood Wood Oil, Potassium Sorbate, Sodium Cocoyl Glutamate, Glucose, Citric Acid, Glyceryl Caprylate, Polyglyceryl-6 Oleate, Thyme Leaf Oil, Chlorella Extract, Sodium Surfactin, Lactic Acid, Sodium Lactate, Farnesol

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252296salicylic acid 0.5 % Topical GelPSN3
252296salicylic acid 0.005 MG/MG Topical GelSCD3
252296salicylic acid 0.5 % Topical GelSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51417-0005-12025-01-30C16284748780-12cef2736-a37c-d83d-e063-dadaa90ab31fClearcalm Non-Drying Acne Treatment Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51417-0005-1Clearcalm Non-Drying Acne Treatment15 mL in 1 TUBEGEL153
51417-0005-1Clearcalm Non-Drying Acne Treatment1 in 1 BOXGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51417-0005CLEARCALM NON-DRYING ACNE TREATMENT (SALICYLIC ACID) GEL [REN LTD.]3Legacy NDC, 2 package rows20231110_da720f0a-d71d-4ad0-9247-a8d3f85210ed.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51417-000551417-0005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
09c36f46-85c7-57be-e063-6394a90a7f26da720f0a-d71d-4ad0-9247-a8d3f85210ed2023-11-09WarningsExact identifier
spl id: 09c36f46-85c7-57be-e063-6394a90a7f26
spl set id: da720f0a-d71d-4ad0-9247-a8d3f85210ed

Reported adverse events (FAERS/openFDA)#

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