Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1fad69c9-30af-49c6-bb9f-21805b1bae31
Route
TOPICAL
Published
Effective Date 2009-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 mL)
Inactive Ingredients
Alcohol Edetate Disodium Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2003-08-31

Description

Salicylic acid 2.0% w/w

Purpose

Acne medication


Medication Information

Warnings and Precautions



Purpose
Acne medication

Description

Salicylic acid 2.0% w/w

Use
for the treatment of acne
Section 42229-5



Section 50566-9



Section 50568-5



Section 50569-3


Section 53413-1



Section 53414-9



Warnings

For external use only. Flammable, keep away from fire or flame.

Directions
  • Cleanse the skin thoroughly before applying medication
  • Use the pad to wipe the entire affected area one to three times daily

  • 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

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

Active Ingredient
Salicylic acid 2.0% w/w

Other Information
  • KEEP TIGHTLY CLOSED
  • Store at room temperature: 15°- 30° C (59° - 86° F)
Inactive Ingredients
alcohol, disodium EDTA, fragrance, isoceteth-20, polyolprepolymer-15, purified water, triethalnolamine

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.

Label Information Representative Label

Compare to the active ingredient in Oxy®*

Daily Cleansing Pads

2% Salicylic Acid acne medication

Aggressively treats and helps prevent pimples

MAXIMUM STRENGTH

90 PADS



*This product is not manufactured or distributed by The Mentholatum Co. Inc., owner of the registered trademark, OXY®.










Structured Label Content

Use (USE)
for the treatment of acne
Warnings and Precautions (34071-1)



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)



Purpose (PURPOSE)
Acne medication

Warnings (WARNINGS)

For external use only. Flammable, keep away from fire or flame.

Directions (DIRECTIONS)
  • Cleanse the skin thoroughly before applying medication
  • Use the pad to wipe the entire affected area one to three times daily

  • 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

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

Other Information (OTHER INFORMATION)
  • KEEP TIGHTLY CLOSED
  • Store at room temperature: 15°- 30° C (59° - 86° F)
Inactive Ingredients (INACTIVE INGREDIENTS)
alcohol, disodium EDTA, fragrance, isoceteth-20, polyolprepolymer-15, purified water, triethalnolamine

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.

Label Information Representative Label (LABEL INFORMATION - REPRESENTATIVE LABEL)

Compare to the active ingredient in Oxy®*

Daily Cleansing Pads

2% Salicylic Acid acne medication

Aggressively treats and helps prevent pimples

MAXIMUM STRENGTH

90 PADS



*This product is not manufactured or distributed by The Mentholatum Co. Inc., owner of the registered trademark, OXY®.










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Raw Label Data

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