FDA Label for Raf Five - Spot On Salicylic Acid Roll-on Acne Treatment

View Indications, Usage & Precautions

Raf Five - Spot On Salicylic Acid Roll-on Acne Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Cosmetic Solutions Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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


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