Replenix®

Replenix®
SPL v4
SPL
SPL Set ID 811dbf95-2b39-45c5-99a2-33c3c9d19570
Route
TOPICAL
Published
Effective Date 2019-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Sodium Lauroyl Sarcosinate Sodium Methyl Cocoyl Taurate Peg-7 Glyceryl Cocoate Disodium Cocoamphodiacetate Potassium Hydroxide Glycolic Acid Green Tea Leaf Cucumber Zinc Pidolate Copper Pidolate Willow Bark Hydroxyethyl Cellulose (100 Mpa.s At 2%) Phenoxyethanol Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-03-15

Description

Drug Facts

Purpose

Acne medication


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. Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.

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

Water, Sodium Lauroyl Sarcosinate, Sodium Methyl Cocoyl Taurate, PEG-7 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Potassium Hydroxide, Glycolic Acid, Green Tea Extract, Cucumber Extract, Zinc PCA, Copper PCA, Willow Bark Extract, Hydroxyethylcellulose, Phenoxyethanol, Disodium EDTA.

Principal Display Panel 200 Ml Bottle Label

REPLENiX®

ACNE SOLUTIONS

Gly/Sal® 2-2

Foaming

Cleanser

Glycolic Acid 2%

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. Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.

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)

Water, Sodium Lauroyl Sarcosinate, Sodium Methyl Cocoyl Taurate, PEG-7 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Potassium Hydroxide, Glycolic Acid, Green Tea Extract, Cucumber Extract, Zinc PCA, Copper PCA, Willow Bark Extract, Hydroxyethylcellulose, Phenoxyethanol, Disodium EDTA.

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

REPLENiX®

ACNE SOLUTIONS

Gly/Sal® 2-2

Foaming

Cleanser

Glycolic Acid 2%

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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