Label: RAF FIVE - AFTER HOURS SALICYLIC ACID MOISTURIZING- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66163-4454-1 - Packager: Cosmetic Solutions LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 26, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
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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.
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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
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
RAF FIVE - AFTER HOURS SALICYLIC ACID MOISTURIZING
salicylic acid lotionProduct 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)
