Replenix Gly-sal 2-2

Replenix Gly-sal 2-2
SPL v1
SPL
SPL Set ID 6c6bbedc-e2ee-46a0-8800-e356bdd262b0
Route
TOPICAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Cocamidopropyl Betaine Edetate Disodium Glycolic Acid Linoleamidopropyl Propylene Glycol-dimonium Chloride Phosphate Peg-150 Distearate Polysorbate 20 Propylene Glycol Water Fd&c Red No. 40 Sodium C12-15 Alketh-15 Sulfonate Sodium C14-16 Olefin Sulfonate Trolamine Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-23

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.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Warnings

For external use only

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

Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, PEG-150 Distearate, Polysorbate-20, Propylene Glycol, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140].

Principal Display Panel 200 Ml Bottle Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Gly/Sal 2-2

Pore Refining

Cleanser

Glycolic Acid 2%

Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]


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.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Purpose

Acne medication

Warnings

For external use only

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)

Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, PEG-150 Distearate, Polysorbate-20, Propylene Glycol, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate, Triethanolamine, Yellow #5 [CI-19140].

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

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

Gly/Sal 2-2

Pore Refining

Cleanser

Glycolic Acid 2%

Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Available

Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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