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PRESTO

Medically reviewed on December 15, 2017.

Dosage form: cream
Ingredients: ZINC OXIDE 5g in 1mL
Labeler: GADAL Laboratories, Inc
NDC Code: 53113-162

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ACTIVE INGREDIENT
 Active ingredient Purpose
Zinc Oxide 5.0 % Skin Protectant

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
questions@prestoabsorbent.com
© 2017 Drylock Technologies Ltd.
Made in USA with domestic and imported materials.

PRESTO 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-162
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
APIS CERANA WORKER SECRETION 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) 
CHOLECALCIFEROL 
CORN OIL 
CYCLOMETHICONE 4 
CYCLOMETHICONE 5 
HYDROGENATED CASTOR OIL 
DIMETHICONE 
DMDM HYDANTOIN 
ETHYLHEXYL PALMITATE 
GLYCERIN 
HEXYL LAURATE 
ISOPROPYL PALMITATE 
SODIUM CHLORIDE 
TOCOPHEROL 
VITAMIN A PALMITATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:53113-162-06177 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/01/2017
Labeler - GADAL Laboratories, Inc (841305639)
Establishment
NameAddressID/FEIOperations
GADAL Laboratories, Inc841305639MANUFACTURE(53113-162)

 
GADAL Laboratories, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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