NDC 53113-162

PRESTO

Zinc Oxide

PRESTO is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories, Inc. The primary component is Zinc Oxide.

• Product ID: 53113-162_5a175b56-6c10-4c25-bf7a-91cc75374c51
• NDC: 53113-162
• Product Type: Human Otc Drug
• Proprietary Name: PRESTO
• Generic Name: Zinc Oxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-06-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: GADAL Laboratories, Inc
• Substance Name: ZINC OXIDE
• Active Ingredient Strength: 5 g/mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53113-162-06

177 mL in 1 BOTTLE (53113-162-06)

• Marketing Start Date: 2017-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-162-06 [53113016206]

PRESTO CREAM

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-06-01

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	5 g/mL

OpenFDA Data

• SPL SET ID: 8e20513d-f257-4b2a-ab58-348bc9eddfe1
• Manufacturer:
  • GADAL Laboratories, Inc
• UNII:
  • SOI2LOH54Z

NDC Crossover Matching brand name "PRESTO" or generic name "Zinc Oxide"

NDC	Brand Name	Generic Name
53113-162	PRESTO	PRESTO
0316-2082	Blue Lizard Active SPF 50	zinc oxide
0316-2011	Blue Lizard Baby SPF 50	zinc oxide
0316-2012	Blue Lizard Kids SPF 50	zinc oxide
0316-2081	Blue Lizard Kids SPF 50	zinc oxide
0316-2013	Blue Lizard Sensitive SPF 50	zinc oxide
0316-2083	Blue Lizard Sensitive SPF 50	zinc oxide
0316-2080	Blue Lizard Sport SPF 50	zinc oxide
0132-0194	Boudreauxs	Zinc Oxide
0132-0323	Boudreauxs	Zinc Oxide
0132-0324	Boudreauxs	Zinc Oxide
0132-0333	Boudreauxs	Zinc Oxide
0132-0334	Boudreauxs	Zinc Oxide
0132-0325	Boudreauxs Rash Kicking Kit	Zinc oxide
0201-4008	CALENDULA DIAPER RASH	ZINC OXIDE
0164-2189	CALENDULA DIAPER RASH CREAM	ZINC OXIDE
0299-4110	Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50	zinc oxide
0178-0330	DR SMITHS DIAPER	Zinc Oxide
0178-0340	Dr Smiths Diaper Rash	Zinc Oxide
0178-0345	Dr Smiths Diaper Rash	Zinc Oxide
0178-0348	Dr Smiths Diaper Rash	Zinc Oxide
0178-0370	Dr. Smiths Rash and Skin	Zinc Oxide
0363-0402	Walgreen Maximum Strength Diaper Rash	ZINC OXIDE
0363-0994	Walgreens 50 Baby Mineral Sunscreen	Zinc Oxide
0363-0988	Walgreens SPF 50 Mineral Sunscreen	ZINC OXIDE
0363-4008	Walgreens SunscreenSPF 45 SPF 45	ZINC OXIDE
0164-2207	WHITE MALLOW DIAPER RASH CREAM	ZINC OXIDE
0168-0062	ZINC OXIDE	ZINC OXIDE
0363-1020	Zinc Oxide	ZINC OXIDE
0363-1226	Zinc oxide	Zinc oxide