FDA.reportPublic FDA data

153 Remedy Specialized Zinc Oxide Paste

Manufacturer
Medline Industries, LP
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-08-26 01:02:09

Label at a glance#

ProductMedline
Active ingredientZINC OXIDE, WHITE PETROLATUM
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

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

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again withinn a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-153-442025-09-03C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste
53329-153-442025-09-03C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste
53329-153-442025-09-03C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste
53329-153-442025-07-29C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste
53329-153-442025-07-29C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste
53329-153-442025-07-29C16284748780-13b156c62-2581-fb37-e063-e6dba90a4e07153 Remedy Specialized Zinc Oxide Paste

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-153-44GM - Gram53329-15377ce5cc5-68f9-4fd8-9316-01c6e06c2d3012024-07-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-15353329-153-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WHITE PETROLATUMB6E5W8RQJ4ACTIB
HEXYL LAURATE4CG9F9W01QIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-10-29full-release2026-06-01 01:41:04
32025-09-03full-release2026-06-01 01:12:30

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
ndc (package): 53329-153-44
ndc (product): 53329-153
ndc11 (package): 53329015344
spl id: 5996485c-7ed2-ecdb-e063-6294a90ad807
spl set id: 0073de92-585d-e01a-e063-6394a90a2ec2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.