drug facts

drug facts
SPL v1
SPL
SPL Set ID 76ac8453-213f-411e-a4ba-71bbed259642
Route
topical
Published
Effective Date 2009-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
salicylic acid (.02 mL)
Inactive Ingredients
citric acid monohydrate edetate disodium 1,3-dimethylol-5,5-dimethyl-hydantoin menthol potash ceteth-20 water

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2003-12-02
Purpose

Acne medication

Description

Salicylic acid 2.0% w/w

Medication Information

Warnings and Precautions



Warnings

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

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

Purpose
Acne medication

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

Description

Salicylic acid 2.0% w/w

Section 42229-5



Section 50566-9



Section 50568-5



Section 50569-3


Section 53413-1



Section 53414-9



Allergy Alert
do not use this product if you have a known allergy to salicylic acid.

Active Ingredient
Salicylic acid 2.0% w/w

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.

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®.





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





Structured Label Content

Warnings and Precautions (34071-1)



Warnings (WARNINGS)

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

Uses (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

Purpose (PURPOSE)
Acne medication

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

Inactive Ingredients (INACTIVE INGREDIENTS)
ammonium laureth sulfate, ammonium xylenesulfonate, citric acid, disodium EDTA, DMDM hydantoin, fragrance, menthol, potassium carbonate, PPG-5-ceteth-20, purified water, simethicone

Section 42229-5 (42229-5)



Section 50566-9 (50566-9)



Section 50568-5 (50568-5)



Section 50569-3 (50569-3)


Section 53413-1 (53413-1)



Section 53414-9 (53414-9)



Allergy Alert (Allergy alert)
do not use this product if you have a known allergy to salicylic acid.

Active Ingredient (ACTIVE INGREDIENT)
Salicylic acid 2.0% w/w

When Using This Product (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 (Keep out of reach of children)

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

Box Information Representative Box (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®.





Label Information Representative Label (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





Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:58.889208 · Updated: 2026-03-14T22:52:14.617580