FDA.reportPublic FDA data

Pro Clear Foam

Manufacturer
RELUMINS LABS LLC | COSMESTHETIC LABS. CORP.
Effective date
2021-07-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:41:13

Label at a glance#

ProductPro Clear Foam
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne

Dosage and administration

Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below
  • 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, glyolic acid, phelledendron amurense bark extract, pear juice ferment filtrate, rehmannia chinensis root extract, houttuynia cordata extract, melia azadirachta leaf extract, scutellaria baicalensis root extract, glycine soja (soybean) seed extract

Package Labels - 2 fl oz (60 mL) - NDC 79061-042-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula with 2% Salicylic Acid

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com

bottle-labelbottle-label

Carton Label

RELUMINS

PRO CLEAR FOAM

Advanced Botanical Formula

Salicylic Acid Acne Treatment

Complete Facial Care For Blemish-Prone Skin

Penetrates Deep • Promotes Clear Skin

PROFESSIONAL SKIN CARE

2 fl oz (60 ml)

EXP:

LOT:

Relumins Labs

USA

183 Locust Ave

West Long Branch, NJ 07764

www.relumins.com

carton-labelcarton-label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79061-042-012022-07-29C16284748780-1e4f33bdf-9f15-d8a0-e053-dadaa90a6e4ea47e4888-9e1f-4344-aeb6-a776c154dd39

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79061-042-01Pro Clear Foam60 mL in 1 BOTTLELIQUID606
79061-042-01Pro Clear Foam1 in 1 CARTONLIQUID16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79061-042PRO CLEAR FOAM (SALICYLIC ACID ACNE TREATMENT) LIQUID [RELUMINS LABS LLC]6Legacy NDC, 2 package rows20210703_a47e4888-9e1f-4344-aeb6-a776c154dd39.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
79061-04279061-042-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLYCOLIC ACID0WT12SX38SIACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
PEAR JUICEF214DLA9BEIACT
REHMANNIA GLUTINOSA ROOT1BEM3U6LQQIACT
HOUTTUYNIA CORDATA FLOWERING TOPRH041UUZ22IACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
SOYBEANL7HT8F1ZODIACT

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
00417e6a-9829-4a59-ae8d-b1c9b9690bfda47e4888-9e1f-4344-aeb6-a776c154dd392021-07-01WarningsExact identifier
spl id: 00417e6a-9829-4a59-ae8d-b1c9b9690bfd
spl set id: a47e4888-9e1f-4344-aeb6-a776c154dd39

Reported adverse events (FAERS/openFDA)#

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