FDA Label for Acne Solutions Emergency

View Indications, Usage & Precautions

Acne Solutions Emergency Product Label

The following document was submitted to the FDA by the labeler of this product Clinique Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENT: BENZOYL PEROXIDE 0.5%


Inactive Ingredient



water [] c12-15 alkyl benzoate [] glycerin [] cetearyl alcohol [] steareth-2 [] sucrose [] steareth-20 [] polyacrylamide [] dimethicone [] glyceryl stearate [] peg-100 stearate [] acetyl glucosamine [] camellia sinensis leaf extract [] caffeine [] yeast extract (faex) [] cola nitida extract [] laminaria saccharina extract [] sea whip extract [] c13-14 isoparaffin [] butylene glycol [] laureth-7 [] chloroxylenol [] phenoxyethanol


Otc - Purpose



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.


Indications & Usage



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

Dosage & Administration



 COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL:

CLINIQUE

ACNE SOLUTIONS

EMERGENCY

GEL-LOTION

BENZOYL PEROXIDE

ACNE MEDICATION

ALL SKIN TYPES



0.5 FL OZ LIQ. / 15 ML




CLINIQUE LABORATORIES DIST
NEW YORK, NEW YORK 10022








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