Other
Drug Facts
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.
Replenix Gly-sal 2-2 Liquid
FDA Label NDC 51326-925
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Replenix Gly-sal 2-2 (NDC 51326-925). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Salicylic Acid USP, 2%
Purpose
Acne medication
Uses
Skin cleanser for the treatment of acne.
Warnings
For external use only
Otc - Keep Out Of Reach Of Children
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
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]
Principal Display Panel (200 ml Bottle Label)
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