Medicated Acne Pads: Package Insert and Label Information

MEDICATED ACNE PADS — salicylic acid swab
H and P Industries, Inc. dba Triad Group

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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.

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 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

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
label
(click image for full-size original)

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)

box
(click image for full-size original)
MEDICATED ACNE PADS salicylic acid swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-7701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID .02 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN
MENTHOL
POTASH
CETETH-20
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50730-7701-0 1 JAR (JAR) in 1 BOX contains a JAR
1 55 SWAB (SWAB) in 1 JAR This package is contained within the BOX (50730-7701-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/02/2003
Labeler — H and P Industries, Inc. dba Triad Group (050259597)

Revised: 12/2009 H and P Industries, Inc. dba Triad Group

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