Label: ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT- benzoyl peroxide lotion
- NDC Code(s): 49527-117-01, 49527-117-02, 49527-117-03
- Packager: CLINIQUE LABORATORIES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 22, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
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Directions
DIRECTIONS:
- CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS 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 OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
- IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DOY OR EVERY OTHER DAY
- IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR
- FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION
- Uses
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WARNINGS
WARNING: FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
- SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME
- AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
- AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH
- AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
- SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION
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Inactive ingredients
water\aqua\eau∙cyclopentasiloxane∙butylene glycol∙cyclohexasiloxane∙ceteareth-20∙dimethicone∙sucrose∙camellia sinensis (green tea) leaf extract∙hordeum vulgare (barley) extract\extrait d'orge∙acetyl glucosamine∙lactobacillus ferment∙poria cocos sclerotium extract∙polymethyl methacrylate∙laminaria saccharina extract∙gentiana lutea (gentian) root extract∙astrocaryum murumuru seed butter∙acrylamide/sodium acryloyldimethyltaurate copolymer∙myristyl alcohol∙glycerin∙zeolite∙algae extract∙linoleic acid∙10-hydroxydecanoic acid∙cucumis sativus (cucumber) fruit extract∙caffeine∙ cholesterol∙tocopheryl acetate∙bisabolol∙polysorbate 80∙sodium hyaluronate∙propylene glycol dicaprate∙capryloyl glycine∙helianthus annuus (sunflower) seed extract∙quaternium-22∙caprylyl glycol∙isohexadecane∙xanthan gum∙disodiumedta∙chloroxylenol∙phenoxyethanol∙titanium dioxide (ci 77891) [iln47611]
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) GLYCERIN (UNII: PDC6A3C0OX) CHOLESTEROL (UNII: 97C5T2UQ7J) XANTHAN GUM (UNII: TTV12P4NEE) SUCROSE (UNII: C151H8M554) BARLEY (UNII: 5PWM7YLI7R) GLUCOSAMINE (UNII: N08U5BOQ1K) GENTIANA LUTEA ROOT (UNII: S72O3284MS) SACCHAROMYCES LYSATE (UNII: R85W246Z1C) MYRISTYL ALCOHOL (UNII: V42034O9PU) LINOLEIC ACID (UNII: 9KJL21T0QJ) CUCUMBER (UNII: YY7C30VXJT) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE) FU LING (UNII: XH37TWY5O4) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S) (UNII: 2RX4MI2LCX) ZEOLITE A (UNII: Y3NG9WF08W) AGAR, UNSPECIFIED (UNII: 89T13OHQ2B) 10-HYDROXYDECANOIC ACID (UNII: NP03XO416B) CAFFEINE (UNII: 3G6A5W338E) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) SUNFLOWER SEED (UNII: R9N3379M4Z) QUATERNIUM-22 (UNII: MXO138JCBP) ISOHEXADECANE (UNII: 918X1OUF1E) CHLOROXYLENOL (UNII: 0F32U78V2Q) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-117-01 1 in 1 CARTON 12/21/2023 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49527-117-02 1 in 1 CARTON 12/21/2023 2 30 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49527-117-03 1 in 1 CARTON 12/21/2023 3 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 12/21/2023 Labeler - CLINIQUE LABORATORIES LLC (044475127) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Accupac, LLC 071609663 pack(49527-117) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 pack(49527-117) Establishment Name Address ID/FEI Business Operations Vee Pak, LLC dba Voyant Beauty 874763303 manufacture(49527-117) Establishment Name Address ID/FEI Business Operations PALC 078364654 pack(49527-117) , label(49527-117) Establishment Name Address ID/FEI Business Operations Northtec Keystone 949264774 pack(49527-117) , label(49527-117)
