Medline DailyMed Label

Key Label Information#

Active Ingredients And Purpose

Active ingredients

White petrolatum 49% w/w Zinc oxide 15% w/w

Purpose

Skin protectant

Uses

temporarily protects minor cuts, scrapes, and burns temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Directions And Dosage

Directions

for skin protection: apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other Label Information

Inactive ingredients

carboxymethylcellulose sodium, cetyl PEG/PPG-10/1 dimethicone, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

Package Label

Label Images#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1494207	petrolatum 49 % / zinc oxide 15 % Paste	PSN	4
1494207	petrolatum 0.49 MG/MG / zinc oxide 0.15 MG/MG Paste	SCD	4
1494207	Petrolatum 0.49 MG/MG / ZNO 0.15 MG/MG Paste	SY	4
1494207	petrolatum 49 % / zinc oxide 15 % Paste	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-153-44	2025-09-03	C162847	48780-1	3b156c62-2581-fb37-e063-e6dba90a4e07	153 Remedy Specialized Zinc Oxide Paste
53329-153-44	2025-09-03	C162847	48780-1	3b156c62-2581-fb37-e063-e6dba90a4e07	153 Remedy Specialized Zinc Oxide Paste
53329-153-44	2025-07-29	C162847	48780-1	3b156c62-2581-fb37-e063-e6dba90a4e07	153 Remedy Specialized Zinc Oxide Paste
53329-153-44	2025-07-29	C162847	48780-1	3b156c62-2581-fb37-e063-e6dba90a4e07	153 Remedy Specialized Zinc Oxide Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-153-44	Medline	113 g in 1 TUBE	PASTE	113		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-153-44	GM - Gram	53329-153	77ce5cc5-68f9-4fd8-9316-01c6e06c2d30	1	2024-07-12

Products#

Medline
white petrolatum, zinc oxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-153	53329-153-44

Ingredients#

Name, UNII, Kind table
Name	UNII	Kind
ZINC OXIDE	SOI2LOH54Z	ACTIB
HEXYL LAURATE	4CG9F9W01Q	IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)	035JKJ76MT	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
GLYCERIN	PDC6A3C0OX	IACT
STEARIC ACID	4ELV7Z65AP	IACT
WHITE PETROLATUM	B6E5W8RQJ4	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
WATER	059QF0KO0R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT

Complete SPL Sections#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

White petrolatum 49% w/w Zinc oxide 15% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects minor cuts, scrapes, and burns temporarily protects and helps relieve chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

for skin protection: apply as needed for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

store at 15°C-30°C (59°F-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, cetyl PEG/PPG-10/1 dimethicone, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com ©2024 Medline and Medline Remedy are registered trademarks of Medline Industries, LP. Made in India. Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA 1-800-MEDLINE REF: 325614

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2025-09-03	full-release	2026-06-01 01:12:30