SPL v1
SPL
SPL Set ID b60f69ba-cc02-6271-e053-2a95a90a95cd
Route
TOPICAL
Published
Effective Date 2016-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Cocamidopropyl Betaine Sodium Lauroyl Sarcosinate Edetate Disodium Anhydrous Fd&c Yellow No. 5 Propylene Glycol Melaleuca Alternifolia Leaf Fd&c Blue No. 1 Water Glycerin Menthol Sodium Laureth Sulfate Ammonium Chloride Phenoxyethanol Peg-150 Distearate Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-12-11

Description

Purpose Acne treatment


Medication Information

Warnings and Precautions

Warnings

For external use only

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Indications and Usage

Uses

  • For the management of acne
Dosage and Administration

Directions

Squeeze a nickel size amount onto fingertips and gently massage onto face. Spread in small circular motions, then rinse and glow. For best results, use daily.

Description

Purpose Acne treatment

Section 50565-1

Keep out of reach of children

If swallowed get medical help or contact a poison control center right away.

Section 50567-7

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betain, Glycerin, Ammonium Chloride, Sodium Lauroyl Sarcosinate, Propylene Glycol, Fragrance, PEG-150 Distearate, Disodium EDTA, Iodopropynyl Butylcarbamate, Menthol, Melalueca Alternnifolia (Tea Tree) Leaf Extract, FD&C Yellow No.5, FD&C Blue No.1.

Section 51945-4

Section 55105-1

Purpose

Acne treatment

Section 55106-9

Active Ingredient

Salicylic Acid (2.0%)

Section 60561-8

Other Information

Store at room temperature

Questions / Comments?

1-855-345-5575


Structured Label Content

Indications and Usage (34067-9)

Uses

  • For the management of acne
Dosage and Administration (34068-7)

Directions

Squeeze a nickel size amount onto fingertips and gently massage onto face. Spread in small circular motions, then rinse and glow. For best results, use daily.

Warnings and Precautions (34071-1)

Warnings

For external use only

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

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 50567-7 (50567-7)

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Section 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betain, Glycerin, Ammonium Chloride, Sodium Lauroyl Sarcosinate, Propylene Glycol, Fragrance, PEG-150 Distearate, Disodium EDTA, Iodopropynyl Butylcarbamate, Menthol, Melalueca Alternnifolia (Tea Tree) Leaf Extract, FD&C Yellow No.5, FD&C Blue No.1.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acne treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid (2.0%)

Section 60561-8 (60561-8)

Other Information

Store at room temperature

Questions / Comments?

1-855-345-5575


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)