RAF FIVE - SPOT ON SALICYLIC ACID ROLL-ON ACNE TREATMENT- salicylic acid cream

RAF Five - Spot On Salicylic Acid Roll-On Acne Treatment by

Drug Labeling and Warnings

RAF Five - Spot On Salicylic Acid Roll-On Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

Stop use and ask a doctor.

• If irritation becomes severe.

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.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 15 g Bottle Carton

RAF™
FIVE

SPOT ON

SALICYLIC ACID
ROLL-ON
ACNE TREATMENT
with CBD

Net Wt.
0.5oz. / 15g

INGREDIENTS AND APPEARANCE

RAF FIVE - SPOT ON SALICYLIC ACID ROLL-ON ACNE TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4455
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Pentylene Glycol (UNII: 50C1307PZG)
Propanediol (UNII: 5965N8W85T)
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)
Niacinamide (UNII: 25X51I8RD4)
Cetearyl Olivate (UNII: 58B69Q84JO)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Sorbitan Olivate (UNII: MDL271E3GR)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cannabidiol (UNII: 19GBJ60SN5)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Ergothioneine (UNII: BDZ3DQM98W)
Artemisia Vulgaris Top Oil (UNII: 72Q967Y48V)
Bergamot Oil (UNII: 39W1PKE3JI)
Lemon Oil, Cold Pressed (UNII: I9GRO824LL)
Eucalyptus Oil (UNII: 2R04ONI662)
Juniperus Virginiana Oil (UNII: PAD4FN7P2G)
Spearmint Oil (UNII: C3M81465G5)
Grape Seed Oil (UNII: 930MLC8XGG)
Polydextrose (UNII: VH2XOU12IE)
Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Betasizofiran (UNII: 2X51AD1X3T)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Caprylyl Glycol (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-4455-1	15 g in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/01/2021

Labeler - Cosmetic Solutions LLC (807907928)