Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0c6624fd-88f9-402c-8ac2-bc278242b484
Route
TOPICAL
Published
Effective Date 2015-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Alcohol Glycerin Aloe Vera Leaf Water Peg-8/smdi Copolymer Glycolic Acid Limonene, (+)- Ammonia Tea Tree Oil Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-08

Description

Active Ingredient - Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings:

  • For external use only.
  • Overuse of this product will cause dryness.
Indications and Usage

Uses: For treatment of Acne

Dosage and Administration

Gently rub pad over any area in need. Use every other night or as recommended by your skin care prifessional. Keep the lid securely closed to prevent evapration. To avoid dryness, do not overuse. Not recommended for those with aspirin / NASID allergies.

Description

Active Ingredient - Salicylic Acid 2%

Section 50565-1

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • When using other topical medication at the same time.
Section 50567-7

When using this product:

  • Avoid contact with the eyes, lips and mouth.
  • Using 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.
  • If sensitive to the sun or when increased sun exposure is expected, use a sunscreen.
Section 50570-1

Do not use if you have sensitive skin.

Section 51727-6

Inactive Ingredients:

Alcohol Denat., Water (Aqua), Glycerin, PEG-8/SMDI Copolymer, Glycolic Acid, Aloe Barbadensis Leaf Juice, Ammonium Hydroxide, Melaleuca Alternifolia Leaf Oil, Allantoin, Limonene.

Section 51945-4

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredient - Salicylic Acid 2%


Structured Label Content

Indications and Usage (34067-9)

Uses: For treatment of Acne

Dosage and Administration (34068-7)

Gently rub pad over any area in need. Use every other night or as recommended by your skin care prifessional. Keep the lid securely closed to prevent evapration. To avoid dryness, do not overuse. Not recommended for those with aspirin / NASID allergies.

Warnings and Precautions (34071-1)

Warnings:

  • For external use only.
  • Overuse of this product will cause dryness.
Section 50565-1 (50565-1)

Keep out of reach of children:

  • If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop use and ask a doctor:

  • If severe skin irritation occurs.
  • When using other topical medication at the same time.
Section 50567-7 (50567-7)

When using this product:

  • Avoid contact with the eyes, lips and mouth.
  • Using 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.
  • If sensitive to the sun or when increased sun exposure is expected, use a sunscreen.
Section 50570-1 (50570-1)

Do not use if you have sensitive skin.

Section 51727-6 (51727-6)

Inactive Ingredients:

Alcohol Denat., Water (Aqua), Glycerin, PEG-8/SMDI Copolymer, Glycolic Acid, Aloe Barbadensis Leaf Juice, Ammonium Hydroxide, Melaleuca Alternifolia Leaf Oil, Allantoin, Limonene.

Section 51945-4 (51945-4)

Manufactured for DermaQuest®, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredient - Salicylic Acid 2%


Advanced Ingredient Data


Raw Label Data

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