FDA Label for Medicated Acne Pads

View Indications, Usage & Precautions

Medicated Acne Pads Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. 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.

Active Ingredient



Salicylic acid 2.0% w/w

Purpose



Acne medication

Uses



  • for the treatment and management of acne
  • reduces the number of acne pimples and blackheads and allows skin to heal
  • helps to prevent new acne pimples from forming

Warnings



For external use only. Keep away from eyes, lips and other mucous membranes.



Allergy Alert



Do not use this product if you have a known allergy to salicylic acid.

Otc - Ask Doctor/Pharmacist





When Using This Product



use of other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.


Otc - Stop Use





Otc - Pregnancy Or Breast Feeding





Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Cleanse the skin thoroughly before applying medication
  • Use the pad to wipe the entire affected area and discard
  • Do not leave pad on skin for an extended period of time
  • Repeat with a clean pad as necessary to remove remaining traces of dirt
  • 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 of peeling occurs, reduce application to once a day or every other day

Other





Other Information



Store at room temperature: 15°- 30° C (59° - 86° F)

Inactive Ingredients



Ammonium laureth sulfate, ammonium xylenesulfonate, citric acid, disodium EDTA, DMDM hydantoin, fragrance, menthol, potassium carbonate, PPG-5-ceteth-20, purified water, simethicone

Otc - Questions





Label Information - Representative Label



MAXIMUM STRENGTH

ACNE PADS

MEDICATED WITH SALYCYLIC ACID

  • Clean, Treat and Prevent Acne Blemishes
  • Alcohol-free
  • Easy Lift Notch For Easy Removal From Jar
  • 55 PADS



Box Information - Representative Box



MAXIMUM STRENGTH

ACNE PADS


MEDICATED WITH SALYCYLIC ACID

  • Clean, Treat and Prevent Acne Blemishes
  • Alcohol-free
  • Easy Lift Notch For Easy Removal From Jar

  • Compare to STRI-DEX® active ingredients*

    55 PADS (2-1/8" diameter)


    *This product is not manufactured or distributed by Blistex, Inc., owner of the registered trademark STRIDEX®.



* Please review the disclaimer below.