RAF Five - After Hours Salicylic Acid Moisturizing

Manufacturer
Cosmetic Solutions LLC
Effective date
2021-08-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:08

Label at a glance#

ProductRAF Five - After Hours Salicylic Acid Moisturizing
Active ingredientsalicylic acid
Label structure9 sections

Indications and uses

for the management of acne.

Dosage and administration

Cleanse the skin thoroughly before applying this product. Use one to three pumps to cover the face and neck, applying 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 oth...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 1.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

for the management of acne.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Skin irritation and dryness are 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.
  • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor.

  • If irritation becomes severe.

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

  • Cleanse the skin thoroughly before applying this product.
  • Use one to three pumps to cover the face and neck, applying 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), Caprylic/ Capric Triglyceride, Pentylene Glycol, PPG-12/ SMDI Copolymer, Niacinamide, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Squalane, Cetearyl Olivate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Sorbitan Olivate, Cannabidiol, Ergothioneine,Dipotassium Glycyrrhizate, Sodium Hyaluronate, Artemisia Vulgaris Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Limon (Lemon) Peel Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Mentha Citrata Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Vitis Vinifera (Grape) Seed Oil, Glycerin, Citric Acid, Amylopectin Dextrin, Polydextrose, Silica, Caprylhy- droxamic Acid.

SPL UNCLASSIFIED SECTION

Distributed by ILERA DERM LLC,
a subsidiary of Zelira Therapeutics LTD.
5110 Campus Drive Plymouth Meeting, PA 19462

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAF™
FIVE

AFTER
HOURS

SALICYLIC ACID
MOISTURIZING LOTION
ACNE TREATMENT

with CBD

1.7 fl. oz. / 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-4454-12023-01-30C16284748780-1f386c64a-4a27-0266-e053-dadaa90a7c1aRAF™ Five - After Hours Salicylic Acid Moisturizing

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-4454-1RAF Five - After Hours Salicylic Acid Moisturizing50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-4454RAF FIVE - AFTER HOURS SALICYLIC ACID MOISTURIZING (SALICYLIC ACID) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20210829_2c78cfcf-991f-40f3-ab8a-547d8d21964a.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-445466163-4454-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
120371a7-2a0e-4d21-863c-4fde74bdd4822c78cfcf-991f-40f3-ab8a-547d8d21964a2021-08-26WarningsExact identifier
spl id: 120371a7-2a0e-4d21-863c-4fde74bdd482
spl set id: 2c78cfcf-991f-40f3-ab8a-547d8d21964a

Reported adverse events (FAERS/openFDA)#

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