Acne Solutions

Acne Solutions
SPL v3
SPL
SPL Set ID 0d0cfec0-5d18-c347-e063-6394a90a912c
Route
TOPICAL
Published
Effective Date 2023-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Butylene Glycol Dimethicone Astrocaryum Murumuru Seed Butter Glycerin Cholesterol Xanthan Gum Sucrose Barley Glucosamine Gentiana Lutea Root Saccharomyces Lysate Myristyl Alcohol Linoleic Acid Cucumber .alpha.-tocopherol Acetate, Dl- Hyaluronate Sodium Caprylyl Glycol Edetate Disodium Phenoxyethanol Water Cyclomethicone 5 Cyclomethicone 6 Polyoxyl 20 Cetostearyl Ether Green Tea Leaf Limosilactobacillus Reuteri Fu Ling Poly(methyl Methacrylate; 450000 Mw) Acrylamidopropyltrimonium Chloride/acrylamide Copolymer (400 Mpa.s) Zeolite A Agar, Unspecified 10-hydroxydecanoic Acid Caffeine .alpha.-bisabolol, (+)- Polysorbate 80 Propylene Glycol Dicaprate Capryloyl Glycine Sunflower Seed Quaternium-22 Isohexadecane Chloroxylenol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-21

Description

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

Purpose

Acne Treatment


Medication Information

Warnings and Precautions

WARNING: FOR EXTERNAL USE ONLY

Purpose

Acne Treatment

Description

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

Uses

Treats Acne

Clears acne blemishes

Helps prevent development of new acne blemishes

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE
Section 50567-7

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
Section 50570-1

DO NOT USE IF YOU

  • HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 55106-9

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

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
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 ℮


Structured Label Content

Uses

Treats Acne

Clears acne blemishes

Helps prevent development of new acne blemishes

Warnings and Precautions (34071-1)

WARNING: FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE
Section 50567-7 (50567-7)

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
Section 50570-1 (50570-1)

DO NOT USE IF YOU

  • HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE
Section 55106-9 (55106-9)

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

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
Inactive Ingredients (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 (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 ℮


Advanced Ingredient Data


Raw Label Data

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