Otc - Active Ingredient
ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%
Acne Solutions Lotion
FDA Label NDC 49527-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clinique Laboratories Llc for the product Acne Solutions (NDC 49527-117). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, purpose, directions, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
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
Treats Acne
Clears acne blemishes
Helps prevent development of new acne blemishes
Warnings
WARNING: FOR EXTERNAL USE ONLY
Otc - Do Not Use
DO NOT USE IF YOU
- HAVE VERY SENSITIVE SKIN
- ARE SENSITIVE TO BENZOYL PEROXIDE
Otc - When Using
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
Otc - Stop Use
STOP USE AND ASK A DOCTOR IF
- IRRITATION BECOMES SEVERE
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
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
CLINIQUE
acne solutions
all-over clearing
treatment
oil-free
STEP 3
BENZOYL PEROXIDE
ACNE MEDICATION
ALL SKIN TYPES
1.7 FL.OZ.LIQ./50 ml ℮
Principal Display Panel (47611)
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