NDC 53329-004

Soothe and Cool Protect

Zinc Oxide And White Petrolatum

Soothe and Cool Protect is a Topical Paste in the Human Otc Drug category. It is labeled and distributed by Medline Industries, Inc.. The primary component is Zinc Oxide; Petrolatum.

• Product ID: 53329-004_7f3ac9ed-595e-f82e-e053-2a91aa0a8699
• NDC: 53329-004
• Product Type: Human Otc Drug
• Proprietary Name: Soothe and Cool Protect
• Generic Name: Zinc Oxide And White Petrolatum
• Dosage Form: Paste
• Route of Administration: TOPICAL
• Marketing Start Date: 2007-01-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part346
• Labeler Name: Medline Industries, Inc.
• Substance Name: ZINC OXIDE; PETROLATUM
• Active Ingredient Strength: 100 mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 53329-004-02

71 g in 1 TUBE (53329-004-02)

• Marketing Start Date: 2007-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53329-004-02 [53329000402]

Soothe and Cool Protect PASTE

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2007-01-01

NDC 53329-004-10 [53329000410]

Soothe and Cool Protect PASTE

• Marketing Category: OTC monograph final
• Application Number: part346
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2007-01-01
• Marketing End Date: 2018-12-31

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	100 mg/g

OpenFDA Data

• SPL SET ID: 2bd6e71d-5549-7110-e054-00144ff8d46c
• Manufacturer:
  • Medline Industries, Inc.
• UNII:
  • SOI2LOH54Z
  • 4T6H12BN9U
• RxNorm Concept Unique ID - RxCUI:
  • 1043549
  • 1302176
• UPC Code:
  • 0080196668666

NDC Crossover Matching brand name "Soothe and Cool Protect" or generic name "Zinc Oxide And White Petrolatum"

NDC	Brand Name	Generic Name
53329-004	Soothe and Cool Protect	Zinc Oxide and White Petrolatum
53329-993	Soothe and Cool Protect	Petrolatum