RAF FIVE - AFTER HOURS SALICYLIC ACID MOISTURIZING- salicylic acid lotion

RAF Five - After Hours Salicylic Acid Moisturizing by

Drug Labeling and Warnings

RAF Five - After Hours Salicylic Acid Moisturizing 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 1.5%

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.
• 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

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

RAF™
FIVE

AFTER
HOURS

SALICYLIC ACID
MOISTURIZING LOTION
ACNE TREATMENT

with CBD

1.7 fl. oz. / 50 mL

INGREDIENTS AND APPEARANCE

RAF FIVE - AFTER HOURS SALICYLIC ACID MOISTURIZING 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-4454
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ)	salicylic acid	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Pentylene Glycol (UNII: 50C1307PZG)
PPG-12/SMDI Copolymer (UNII: 1BK9DDD24E)
Niacinamide (UNII: 25X51I8RD4)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Squalane (UNII: GW89575KF9)
Cetearyl Olivate (UNII: 58B69Q84JO)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Sorbitan Olivate (UNII: MDL271E3GR)
Cannabidiol (UNII: 19GBJ60SN5)
Ergothioneine (UNII: BDZ3DQM98W)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
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)
Glycerin (UNII: PDC6A3C0OX)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Polydextrose (UNII: VH2XOU12IE)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Caprylhydroxamic Acid (UNII: UPY805K99W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-4454-1	50 mL 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)