replenix®

replenix®
SPL v1
SPL
SPL Set ID 00d1f8af-88de-4a14-80ec-5ee9fd38b191
Route
topical
Published
Effective Date 2024-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Acne medication

Description

Drug Facts


Medication Information

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Uses

Skin cleanser for the treatment of acne.

Purpose

Acne medication

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.
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.

Description

Drug Facts

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.

Active Ingredient

Salicylic Acid USP, 2%

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

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Uses

Skin cleanser for the treatment of acne.

Purpose

Acne medication

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.
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.

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.

Active Ingredient (Active ingredient)

Salicylic Acid USP, 2%

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


Raw Label Data

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