Active Ingredient
| Active ingredient | Purpose |
| Zinc Oxide 5.0 % | Skin Protectant |
Presto
FDA Label NDC 53113-162
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories, Inc for the product Presto (NDC 53113-162). 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 active ingredient, inactive ingredient, keep out of reach of children, indications & usage, warnings, dosage & administration, purpose, presto, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Purified Water, cyclotetrasiloxane , Isopropyl palmitate,
Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane,
Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol
(Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A),
Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor
Oil, Sodium Chloride, DMDM Hydantoin.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Helps treat and prevent diaper rash.
Warnings
For external use only. When using this product avoid contact with eyes. Stop use and ask a doctor if
• Condition worsens.
• Symptoms last more than 7 days or clear up and occur again within a few days.
Dosage & Administration
Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Purpose
• Helps treat and prevent diaper rash.
• Protects chafed skin associated with diaper rash and helps protect from wetness.
Presto
Distributed by:
Drylock Technologies Ltd.
3921 North Hastings Way
Eau Claire, WI 54703
1-877-202-4652
[email protected]
© 2017 Drylock Technologies Ltd.
Made in USA with domestic and imported materials.
Label Image (Lbl53113162)
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