Indications & Usage
This is a prescription fluoride treatment foam used to help prevent dental decay.
Gelato Neutral Ph
FDA Label NDC 68400-138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deepak Products, Inc. for the product Gelato Neutral Ph (NDC 68400-138). 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 indications & usage, warnings, inactive ingredient, storage and handling, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture on incinerate container. Do not spray toward open flame. For professional use only.
Inactive Ingredient
Distilled water, Polaxamer, Triethanolamine, Phosphoric Acid, Sodium Saccharine, Sodium Laureth Sulfate, Hydrofluoric Acid, Xylitol, Potassium Hydroxide, Propellant A31.
Storage And Handling
- Store at controlled room temperature 59-86 F (15-30 C)
- Protect from freezing
Package Label.Principal Display Panel
Entire Label (Img)
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