Replenix Gly-Sal 10-2

Manufacturer: Topiderm, Inc.
Effective date: 2024-08-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:16:44

Label at a glance#

ProductReplenix Gly-Sal 10-2 cleanser

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

Keep away from eyes, lips, and mouth.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
562600	salicylic acid 2 % Medicated Liquid Soap	PSN	1
562600	salicylic acid 20 MG/ML Medicated Liquid Soap	SCD	1
562600	salicylic acid 2 % Facial Cleanser Toner	SY	1
562600	salicylic acid 2 % Facial Scrub	SY	1
562600	salicylic acid 2 % Medicated Liquid Soap	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51326-928-01	Replenix Gly-Sal 10-2cleanser	200 mL in 1 BOTTLE, PLASTIC	LIQUID	200		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51326-928	REPLENIX GLY-SAL 10-2 CLEANSER (SALICYLIC ACID) LIQUID [TOPIDERM, INC.]	1	Current NDC, 1 package rows	20240808_00d1f8af-88de-4a14-80ec-5ee9fd38b191.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Replenix Gly-Sal 10-2 cleanser
salicylic acid
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51326-928	51326-928-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SALICYLIC ACID	O414PZ4LPZ	ACTIB
GREEN TEA LEAF	W2ZU1RY8B0	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
EDETATE CALCIUM DISODIUM	25IH6R4SGF	IACT
GLYCOLIC ACID	0WT12SX38S	IACT
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE	5Q87K461JO	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
WATER	059QF0KO0R	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
SODIUM C12-15 ALKETH-15 SULFONATE	353VA59XH8	IACT
SODIUM C14-16 OLEFIN SULFONATE	O9W3D3YF5U	IACT
TROLAMINE	9O3K93S3TK	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Replenix Gly-Sal 10-2 cleanser	SALICYLIC ACID	Topiderm, Inc.	00d1f8af-88de-4a14-80ec-5ee9fd38b191	2024-08-02	Warnings	Exact identifier ndc (package): 51326-928-01 ndc (product): 51326-928 ndc11 (package): 51326092801 spl id: 812271b8-44af-4393-935a-7cf0a8188887 spl set id: 00d1f8af-88de-4a14-80ec-5ee9fd38b191

Reported adverse events (FAERS/openFDA)#

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