TheraSpec

Manufacturer
Salient Labs, LLC | Pure Source, LLC
Effective date
2019-11-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:01:31

Label at a glance#

ProductTheraSpec Acne Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide

OTC - WHEN USING SECTION

When using this product

  • keep away from eyes, lips and mouth
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair, dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. lf irritation becomes severe, discontinue use: if irritation still continues, consult a doctor.
  • using other topical acne medications at the same time or immediately following the 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

DOSAGE & ADMINISTRATION SECTION

Directions Wet face. Gently massage all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Recommended for use twice daily.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Acrylates Copolymer, Allantoin, Aqua (Deionized Water), Benzyl Alcohol, Ceteareth-20, Dehydroacetic Acid, Hydrolyzed Jojoba Esters, lsopentyldiol, Jojoba Esters, Sodium Cocyl lsethionate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TheraSpec

Acne Cleanser

Principal Display Panel

221 ml

NDC: 52205-003-00

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52205-003-002023-01-30C16284748780-1f386c649-af17-0266-e053-dadaa90a7c1aTheraSpec Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52205-003-00TheraSpecAcne Cleanser221 mL in 1 BOTTLE, PUMPSOAP2215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52205-003THERASPEC ACNE CLEANSER (BENZOYL PEROXIDE) SOAP [SALIENT LABS, LLC]5Legacy NDC, 1 package rows20191118_83e6d5d5-a626-0bdc-e053-2991aa0a6351.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52205-00352205-003-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
9776c82c-6ab8-0be4-e053-2995a90a60bd83e6d5d5-a626-0bdc-e053-2991aa0a63512019-11-16WarningsExact identifier
spl id: 9776c82c-6ab8-0be4-e053-2995a90a60bd
spl set id: 83e6d5d5-a626-0bdc-e053-2991aa0a6351

Reported adverse events (FAERS/openFDA)#

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