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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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

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.

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

PRINCIPAL DISPLAY PANEL - 15 g Bottle Carton
RAF FIVE - SPOT ON SALICYLIC ACID ROLL-ON ACNE TREATMENT 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4455
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66163-4455-115 g in 1 BOTTLE; Type 0: Not a Combination Product03/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/01/2021
Labeler - Cosmetic Solutions LLC (807907928)

Revised: 8/2021
Document Id: d87a753a-e7fd-45e1-a2df-8dc86b86d815
Set id: ee76db56-f8e6-4de2-84b7-e0d902841101
Version: 1
Effective Time: 20210826
 
Cosmetic Solutions LLC