PRESTO- zinc oxide cream

PRESTO by

Drug Labeling and Warnings

PRESTO by is a Otc medication manufactured, distributed, or labeled by GADAL Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

PRESTO 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53113-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
APIS CERANA WORKER SECRETION (UNII: PRG8653U8K)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
CORN OIL (UNII: 8470G57WFM)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53113-162-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2017

Labeler - GADAL Laboratories, Inc (841305639)

Establishment
Name	Address	ID/FEI	Business Operations
GADAL Laboratories, Inc		841305639	MANUFACTURE(53113-162)