Label: RETINOL CLEARING- salicylic acid oil
- NDC Code(s): 68479-141-02
- Packager: Dermalogica, 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 July 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Indications
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Warnings
For external use only
This product contains Retinol, a form of Vitamin A.
- If pregnant or breastfeeding, consult a physician prior to use.
- Avoid contact with eyes. If contact with eyes occurs, flush thoroughly with water.
- Use sunscreen and limit sun exposure when using this product.
- Do not use with other products containing Retinol.
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Directions
When using this product
- Clean the skin thoroughly before applying 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.
- Press button and release to fill dropper. At night, after cleansing, gently press button to dispense 6-10 drops into hands. Smooth over face and neck.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
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Inactive Ingredients
Coconut Alkanes, PPG-15 Stearyl Ether, Rosa Canina Fruit Oil, Simmondsia Chinensis (Jojoba) Seed Oil, C13-15 Alkane, Coco-Caprylate/Caprate, Argania Spinosa Kernel Oil, Caprylic/ Capric Triglyceride, Isopropyl Lauroyl Sarcosinate, Retinyl Propionate, Butyl Avocadate, Phenylethyl Resorcinol, Tanacetum Annuum Flower Oil, Sclareolide, Triolein, Cetyl Alcohol, Hydroxymethoxyphenyl Decanone, Tocopherol, BHT, Alpha-Isomethyl Ionone.
- Questions or comments
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
RETINOL CLEARING
salicylic acid oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68479-141 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 mg in 100 mL Inactive Ingredients Ingredient Name Strength Coconut Alkanes (UNII: 1E5KJY107T) POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) JOJOBA OIL (UNII: 724GKU717M) C13-15 Alkane (UNII: 114P5I43UJ) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ARGAN OIL (UNII: 4V59G5UW9X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J) GLYCERYL TRIOLEATE (UNII: O05EC62663) Butyl Avocadate (UNII: Q86RQ0D402) Cetyl Alcohol (UNII: 936JST6JCN) Retinyl Propionate (UNII: 32JK994WMC) Phenylethyl Resorcinol (UNII: G37UFG162O) Sclareolide (UNII: 37W4O0O6E6) TANACETUM ANNUUM FLOWERING TOP OIL (UNII: E2Q02N1ZC7) 1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Tocopherol (UNII: R0ZB2556P8) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68479-141-02 1 in 1 CARTON 08/27/2019 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 08/27/2019 Labeler - Dermalogica, LLC. (177698560) Establishment Name Address ID/FEI Business Operations Cosway 052400223 MANUFACTURE(68479-141)
