FDA.reportPublic FDA data

088 Curad Zinc Oxide Anorectal Cream

Manufacturer
Medline Industries, LP
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:44:33

Label at a glance#

ProductAnorectal
Active ingredientPETROLATUM, ZINC OXIDE
Label structure9 sections

Indications and uses

For the temporary relief of Local itching and discomfort in the perianal area, associated with anorectal disorders Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues Temporarily protects irritated areas Temporarily relieves burning Temporarily protects the inflamed irritated anorectal surfaces

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age, consult a doctor Apply to the affected area up to 6 times daily or after each bowel movement

Storage and handling

Store at controlled room temperature 68º-77ºF (20º-25ºC). Use only if packaging is intact.

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 80%

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Anorectal Cream

Anorectal Cream

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of

  • Local itching and discomfort in the perianal area, associated with anorectal disorders
  • Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • Temporarily protects irritated areas
  • Temporarily relieves burning
  • Temporarily protects the inflamed irritated anorectal surfaces

Warnings

WARNINGS SECTION

For external use only

  • condition worsens or does not improve within 7 days, consult a doctor
  • Do not exceed the recommended daily dosage unless directed by a doctor
  • In case of bleeding, consult a doctor promptly
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator

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

  • Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years of age, consult a doctor
  • Apply to the affected area up to 6 times daily or after each bowel movement

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 68º-77ºF (20º-25ºC).
  • Use only if packaging is intact.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for: Medline Industries, Inc.

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

1-800-633-5463

REF: CUR006202

RG17ULI

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-088-142022-10-04C16284748780-1d6a99b39-b972-a426-e053-dadaa90af4c2088 Curad Zinc Oxide Anorectal Cream
53329-088-142022-01-28C16284748780-1d6a99b39-b972-a426-e053-dadaa90af4c2088 Curad Zinc Oxide Anorectal Cream

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-08853329-088-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
0370d874-1f5a-d67a-e063-6394a90a1730da9f9e5b-1914-494d-b9de-3e2a14c2fba62023-08-21WarningsExact identifier
spl set id: da9f9e5b-1914-494d-b9de-3e2a14c2fba6

Reported adverse events (FAERS/openFDA)#

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