Replenix®

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (20 mg)

Inactive Ingredients

Green Tea Leaf Cocamidopropyl Betaine Edetate Calcium Disodium Glycolic Acid Linoleamidopropyl Propylene Glycol-dimonium Chloride Phosphate Polysorbate 20 Water Fd&c Red No. 40 Sodium C12-15 Alketh-15 Sulfonate Sodium C14-16 Olefin Sulfonate Trolamine

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-07-26

Medication Information

Purpose

Acne medication

Description

Drug Facts

Uses

Skin cleanser for the treatment of acne.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Directions

Wet affected area, apply, and rinse well.

Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician
If bothersome dryness occurs, reduce application to once a day or every other day.

Active Ingredient

Salicylic Acid USP, 2%

Inactive Ingredients

Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

Principal Display Panel 200 Ml Bottle Label

REPLENiX^®

ACNE SOLUTIONS

Gly/Sal^® 10-2

Cleanser

Glycolic Acid 10%

Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Structured Label Content

Uses

Skin cleanser for the treatment of acne.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

Purpose

Acne medication

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Directions

Wet affected area, apply, and rinse well.

Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician
If bothersome dryness occurs, reduce application to once a day or every other day.

Active Ingredient (Active ingredient)

Salicylic Acid USP, 2%

Inactive Ingredients (Inactive ingredients)

Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

Principal Display Panel 200 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label)

REPLENiX^®

ACNE SOLUTIONS

Gly/Sal^® 10-2

Cleanser

Glycolic Acid 10%

Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.

N. Amityville, NY 11701

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Skin cleanser for the treatment of acne.", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.", "Purpose": "Acne medication", "Warnings": "For external use only Keep away from eyes, lips, and mouth.", "Directions": "Wet affected area, apply, and rinse well. Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician If bothersome dryness occurs, reduce application to once a day or every other day.", "Active ingredient": "Salicylic Acid USP, 2%", "Inactive ingredients": "Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.", "PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label": "REPLENiX ® ACNE SOLUTIONS Gly/Sal ® 10-2 Cleanser Glycolic Acid 10% Salicylic Acid USP, 2% Net 6.7 fl. oz. (200 ml) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information