FDA.reportPublic FDA data

So Clear Repair Spot Treatment

Manufacturer
RemeVerse LLC | Lexia LLC
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:02

Label at a glance#

ProductSo Clear Repair Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Indications and uses

for management of acne

Dosage and administration

After using So Clear Cleanse and Protect, apply to acne blemishes. Allow to dry. Do not wash off. Apply 1 -2 times daily. Discontinue use if increased irritation occurs.

Storage and handling

Store at room temperature. Avoid high excessive heat. (99 degrees F)

Label contents#

Full prescribing information#

So Clear Repair Spot Treatment

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.0%

So Clear Repair Spot Treatment

INACTIVE INGREDIENT SECTION

Water, Magnesium Aluminum Silicate, Allantoin, Polysorbate-20, Sodium Hydroxide, Carbomer, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol

Directions

DOSAGE & ADMINISTRATION SECTION

After using So Clear Cleanse and Protect, apply to acne blemishes. Allow to dry. Do not wash off. Apply 1 -2 times daily. Discontinue use if increased irritation occurs.

Uses

INDICATIONS & USAGE SECTION

for management of acne

SPL UNCLASSIFIED SECTION

Store at room temperature. Avoid high excessive heat. (99 degrees F)

WARNINGS SECTION

Warnings

For external use only

Do not use this medication if you are sensitive to Benzoyl Peroxide.

When using this product § Avoid unnecessary sun exposure and use a sunscreen. § Avoid contact with eyes, lips and mouth. § 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.

Skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

Stop use and ask a doctor if skin irritation become severe

Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation becomes severe.

OTC - PURPOSE SECTION

Acne treatment

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature. Avoid high excessive heat. (99 degrees F)

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

So Clear Repair

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

So Clear LabelSo Clear Label

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
70317-148-152025-08-01C16284748780-13b156c62-29e3-fb37-e063-e6dba90a4e07So Clear Repair Spot Treatment
70317-148-152025-07-29C16284748780-13b156c62-29e3-fb37-e063-e6dba90a4e07So Clear Repair Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70317-148-15So Clear Repair Spot Treatment15 mL in 1 BOTTLE, DISPENSINGLIQUID154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70317-148SO CLEAR REPAIR SPOT TREATMENT LIQUID [REMEVERSE LLC]41 package rows20241218_bd4ad120-3e1b-c324-e053-2a95a90a2bc8.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70317-14870317-148-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
POLYSORBATE 207T1F30V5YHIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CARBOMER 9404Q93RCW27EIACT
ALLANTOIN344S277G0ZIACT
OCTYLPHENOXYETHANOL5G75D69KFOIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
296a1af2-95bd-57c7-e063-6294a90a3e99bd4ad120-3e1b-c324-e053-2a95a90a2bc82024-12-16WarningsExact identifier
spl id: 296a1af2-95bd-57c7-e063-6294a90a3e99
spl set id: bd4ad120-3e1b-c324-e053-2a95a90a2bc8

Reported adverse events (FAERS/openFDA)#

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