REPLENIX GLY-SAL 10-2 CLEANSER- salicylic acid liquid

Replenix Gly-Sal 10-2 by

Drug Labeling and Warnings

Replenix Gly-Sal 10-2 by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid USP, 2%

Purpose

Acne medication

Uses

Skin cleanser for the treatment of acne.

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.

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

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.

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

INGREDIENTS AND APPEARANCE

REPLENIX GLY-SAL 10-2  CLEANSER
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-928
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-928-01	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	07/26/2021

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-928)