Label: DEEP RELIEF ACNE (BLEMISH) TREATMENT- salicylic acid solution
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Contains inactivated NDC Code(s)
NDC Code(s): 70381-121-01, 70381-121-02 - Packager: Murad, 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 February 23, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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Directions
- clean the skin thoroughly before applying product
- 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 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), Propanediol, Glycerin, Pentylene Glycol, Dicaprylyl Carbonate, Behenyl Alcohol, Dimethyl Isosorbide, Physalis Pubescens Fruit Juice, Albatrellus Confluens (Mushroom) Extract, Urea, Yeast Amino Acids, Trehalose, Taurine, Inositol, Betaine, Allantoin, Polylysine, Tocopherol, Pullulan, Caprylic/Capric Triglyceride, Lecithin, Phytosterols, Cetyl Alcohol, Stearyl Alcohol, Glyceryl Stearate, Polyglyceryl-10 Myristate, Menthyl Lactate, Xanthan Gum, Sclerotium Gum, Hydrogenated Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Silica, Disodium EDTA, Sodium Hydroxide, Citric Acid
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- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DEEP RELIEF ACNE (BLEMISH) TREATMENT
salicylic acid solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70381-121 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 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPANEDIOL (UNII: 5965N8W85T) GLYCERIN (UNII: PDC6A3C0OX) PENTYLENE GLYCOL (UNII: 50C1307PZG) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DOCOSANOL (UNII: 9G1OE216XY) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) PHYSALIS PUBESCENS FRUIT JUICE (UNII: GM2TDN9DZI) ALBATRELLUS CONFLUENS FRUITING BODY (UNII: 7UVG8A4DP0) UREA (UNII: 8W8T17847W) AMINO ACIDS, SOURCE UNSPECIFIED (UNII: 0O72R8RF8A) TREHALOSE (UNII: B8WCK70T7I) INOSITOL (UNII: 4L6452S749) TAURINE (UNII: 1EQV5MLY3D) BETAINE (UNII: 3SCV180C9W) ALLANTOIN (UNII: 344S277G0Z) POLY-L-LYSINE (30000-70000 MW) (UNII: 0A1V8JTU2M) TOCOPHEROL (UNII: R0ZB2556P8) PULLULAN (UNII: 8ZQ0AYU1TT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) XANTHAN GUM (UNII: TTV12P4NEE) BETASIZOFIRAN (UNII: 2X51AD1X3T) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB) RAPESEED STEROL (UNII: B46B6DD20U) SOY STEROL (UNII: PL360EPO9J) Product Characteristics Color WHITE (Off-White to Light Beige) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70381-121-02 1 in 1 CARTON 06/09/2022 1 NDC:70381-121-01 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 06/09/2022 Labeler - Murad, LLC (781254792) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 MANUFACTURE(70381-121)