FDA.reportPublic FDA data

REFINE

Manufacturer
SCHWEIGER DERMATOLOGY GROUP
Effective date
2016-09-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:18

Label at a glance#

ProductREFINE Complexion Clearing Pads
Active ingredientsalicylic acid
Label structure11 sections

Indications and uses

For the treatment of acne.

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 the application to once a day or every other day. If going outside...

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.00%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For External use only.

OTC - KEEP OUT OF REACH OF CHILDREN 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
    Keep out of reach of children
  • When using this product, rinse immediately with water if it gets in eyes.
  • If swallowed, consult a physician or poison control center.

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 the application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Additional Information

STORAGE AND HANDLING SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water, SD Alcohol 40B, Propylene Glycol, Salicylic Acid, Glycolic Acid, Mandelic Acid, Polysorbate 20, Calendula Extract, Butylene Glycol, Cucumber Extract, Chamomile Extract, Aloe Baradensis Leaf Extract, Ammonium Hydroxide, Phenoxyethanol, Ethylhexyglycerin.

Questions

OTC - QUESTIONS SECTION

1 888 311 7444

SPL UNCLASSIFIED SECTION

Distributed by: Schweiger Dermatology Group
NY, NY 10019

PRINCIPAL DISPLAY PANEL - 60 Pad Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SKIN SOLUTIONS
dr.Schweiger
NEW YORK

Refine
Complexion Clearing Pads

2% Glycolic + 2% Salicylic Pads

60 pads

PRINCIPAL DISPLAY PANEL - 60 Pad Carton
PRINCIPAL DISPLAY PANEL - 60 Pad Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797892salicylic acid 2 % Medicated PadPSN1
797892salicylic acid 20 MG/ML Medicated PadSCD1
797892salicylic acid 2 % Medicated PadSY1
797892salicylic acid 2 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70911-110-122020-01-31C16284748780-19d75b9d0-61c3-f424-e053-dadaa90a57ceREFINE Complexion Clearing Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70911-110-11REFINE Complexion Clearing Pads60 mL in 1 JARSWAB601
70911-110-12REFINE Complexion Clearing Pads1 in 1 CARTONSWAB11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70911-110REFINE COMPLEXION CLEARING PADS (SALICYLIC ACID) SWAB [SCHWEIGER DERMATOLOGY GROUP]1Legacy NDC, 2 package rows20170101_cb339853-0be4-4498-842b-20ac0eb08e38.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70911-11070911-110-11, 70911-110-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
salicylic acidO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCOLIC ACID0WT12SX38SIACT
MANDELIC ACIDNH496X0UJXIACT
POLYSORBATE 207T1F30V5YHIACT
calendula officinalis flowering top18E7415PXQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHAMOMILEFGL3685T2XIACT
ALOE VERA LEAFZY81Z83H0XIACT
AMMONIA5138Q19F1XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
1b38242c-6a8c-473c-aae7-41592033f4cdcb339853-0be4-4498-842b-20ac0eb08e382016-09-15WarningsExact identifier
spl id: 1b38242c-6a8c-473c-aae7-41592033f4cd
spl set id: cb339853-0be4-4498-842b-20ac0eb08e38

Reported adverse events (FAERS/openFDA)#

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