Raf Five - Spot On Salicylic Acid Roll-on Acne Treatment
FDA Label NDC 66163-4455

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Raf Five - Spot On Salicylic Acid Roll-on Acne Treatment (NDC 66163-4455). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

Salicylic acid 2.0%

Purpose

Acne treatment

Uses

for the management of acne.

Warnings

For external use only

When Using This Product

  • 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

Stop use and ask a doctor.

  • If irritation becomes severe.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Cleanse the skin thoroughly before applying this product.
  • Roll on to 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

Water (Aqua), Pentylene Glycol, Propanediol, PPG -12 /SMDI Copolymer, Niacinamide, Cetearyl Olivate,Ethoxydiglycol, Sorbitan Olivate, Cetearyl Alcohol Cannabidiol, Dipotassium Glycyrrhizate, Ergothioneine, 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, Amylopectin Dextrin, Polydextrose, Hydroxyethylcellulose, Glyceryl Caprylate, Sclerotium Gum, Caprylhydroxamic Acid, Caprylyl Glycol.

Principal Display Panel - 15 G Bottle Carton

RAF™
FIVE

SPOT ON

SALICYLIC ACID
ROLL-ON
ACNE TREATMENT
with CBD

Net Wt.
0.5oz. / 15g

Principal Display Panel (15 g Bottle Carton)

Principal Display Panel (15 g Bottle Carton)

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