FDA.reportPublic FDA data

163 Remedy Specialized Clear Zinc Ointment

Manufacturer
Medline Industries, LP
Effective date
2024-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:00

Label at a glance#

ProductMedline
Active ingredientWHITE PETROLATUM, ZINC OXIDE
Label structure9 sections

Indications and uses

temporarily protects minor: cuts scrapes burns helps prevent and temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

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 product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

White petrolatum 71.5% w/w

Zinc oxide 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor:
  • cuts
  • scrapes
  • burns
  • helps prevent and temporarily protects and helps relieve chapped or cracked skin
  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness

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 within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, 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 product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

OTHER SAFETY INFORMATION

  • protect from freezing
  • avoid excessive heat
  • not made with Natural Rubber Latex

Inactive ingredients

INACTIVE INGREDIENT SECTION

7-dehydrocholesterol, aphanizomemnon flos-aquae (algae) extract, camellia sinenis (green tea) leaf extract, caprylic/capric triglycerides, corn starch, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, guar gum, hydrolyzed soy protein, manuka honey, phospholipids, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:
Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.medline.com

1-800-MEDLINE (633-5453)

REF: MSC092502

V1 RJ22PUA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RJ22PUALabel V1 RJ22PUA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2587748petrolatum 71.5 % / zinc oxide 1 % Topical OintmentPSN1
2587748petrolatum 0.715 MG/MG / zinc oxide 0.01 MG/MG Topical OintmentSCD1
2587748petrolatum 0.715 MG/MG / ZNO 0.01 MG/MG Topical OintmentSY1
2587748petrolatum 71.5 % / zinc oxide 1 % Topical OintmentSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-163-10Medline71 g in 1 TUBEOINTMENT711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-163MEDLINE (WHITE PETROLATUM, ZINC OXIDE) OINTMENT [MEDLINE INDUSTRIES, LP]1Current NDC, 1 package rows20240130_101b9933-c2b8-0fdd-e063-6294a90a306a.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-16353329-163-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WHITE PETROLATUMB6E5W8RQJ4ACTIB
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
HONEYY9H1V576FHIACT
CORN OIL8470G57WFMIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
APHANIZOMENON FLOSAQUAE49VG1X560XIACT
ZINC OXIDESOI2LOH54ZACTIB
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CLOVEK48IKT5321IACT
GUAR GUME89I1637KEIACT
DIMETHICONE92RU3N3Y1OIACT
STARCH, CORNO8232NY3SJIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

Source Document#

Source XML

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, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
ndc (package): 53329-163-10
ndc (product): 53329-163
ndc11 (package): 53329016310
spl id: 101b9933-c2b9-0fdd-e063-6294a90a306a
spl set id: 101b9933-c2b8-0fdd-e063-6294a90a306a

Reported adverse events (FAERS/openFDA)#

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