Replenix Gly-Sal 2-2

Manufacturer
Topiderm, Inc.
Effective date
2024-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:01

Label at a glance#

ProductReplenix Gly-Sal 2-2
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

Skin cleanser for the treatment of acne.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid USP, 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

Skin cleanser for the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
c.service@topixpharm.com

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-925-01Replenix Gly-Sal 2-2200 mL in 1 BOTTLELIQUID2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-925REPLENIX GLY-SAL 2-2 (SALICYLIC ACID) LIQUID [TOPIDERM, INC.]1Current NDC, 1 package rows20240726_6c6bbedc-e2ee-46a0-8800-e356bdd262b0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-92551326-925-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
ndc (package): 51326-925-01
ndc (product): 51326-925
ndc11 (package): 51326092501
spl id: d8528811-6b8f-4332-96c2-753657502234
spl set id: 6c6bbedc-e2ee-46a0-8800-e356bdd262b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.