FDA.reportPublic FDA data

Medline

Manufacturer
Medline Industries, LP
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:39:39

Label at a glance#

ProductMedline
Active ingredientZINC OXIDE, MENTHOL, PETROLATUM
Label structure9 sections

Indications and uses

for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues temporarily protects irritated areas temporarily relieves burning provides temporary relief from skin irritations temporarily protects the inflamed irritated anorectal surface to help make bowel moveme...

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. Apply to the affected area up to 6 times daily Children under 12 years of age : consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.44% w/w

White petrolatum 53% w/w

Zinc oxide 20.6% w/w

Purpose

OTC - PURPOSE SECTION

Analgesic

Protectant

Protectant

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of anorectal itching and discomfort in the perianal area associated with anorectal inflammation
  • temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • temporarily protects irritated areas
  • temporarily relieves burning
  • provides temporary relief from skin irritations
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful
  • temporarily protects inflamed perianal skin
  • temporarily relieves the symptoms of perianal skin irritation
  • may provide a cooling sensation

Warnings

WARNINGS SECTION

For external use only

Allergy Alert: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor

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
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • in case of bleeding

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

  • 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. Apply to the affected area up to 6 times daily
  • Children under 12 years of age: consult a doctor

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION


7-dehydrocholesterol, algae extract (aphanizomenon flos-aquae), beeswax, bisabolol, brassica campestris (rapeseed) sterols, calamine, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, carthamus tinctorius (safflower) seed oil, cetylhydroxyproline palmitamide, cholecalciferol, cocos nucifera (coconut) oil, dimethicone, eugenia caryophyllus (clove) flower extract, glycerin, hexyldecanol, hydrolyzed soy protein, manuka honey, olea europaea (olive) oil, phospholipids, phytonadione, simmondsia chinensis (jojoba) seed oil, stearic acid, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zea mays (corn) starch.

Manufacturing information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of domestic and imported materials

1-800-MEDLINE (633-5463)

REF: MSC092554PACK

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box_V1 RJ22PUABox_V1 RJ22PUA

Packet_V1 RJ22PUAPacket_V1 RJ22PUA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PastePSN3
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / zinc oxide 0.206 MG/MG PasteSCD3
2642278menthol 0.0044 MG/MG / petrolatum 0.53 MG/MG / ZNO 0.206 MG/MG PasteSY3
2642278menthol 0.44 % / petrolatum 53 % / zinc oxide 20.6 % Topical PasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-156-14Medline57 g in 1 TUBEPASTE573
53329-156-44Medline113 g in 1 TUBEPASTE1133
53329-156-83Medline4 g in 1 PACKETPASTE43
53329-156-96Medline144 in 1 BOXPASTE1443

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-156-44GM - Gram53329-15661d08dbd-d8c2-495d-bcab-f4cf9e0b273d12024-07-12

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-15653329-156-83, 53329-156-96, 53329-156-14, 53329-156-44

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
PHYTONADIONEA034SE7857IACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
CORN OIL8470G57WFMIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CHOLECALCIFEROL1C6V77QF41IACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
HEXYLDECANOL151Z7P1317IACT
HONEYY9H1V576FHIACT
OLIVE OIL6UYK2W1W1EIACT
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
ZINC OXIDESOI2LOH54ZACTIB
APHANIZOMENON FLOSAQUAE49VG1X560XIACT
YELLOW WAX2ZA36H0S2VIACT
RAPESEED STEROLB46B6DD20UIACT
FERRIC OXIDE RED1K09F3G675IACT
MENTHOLL7T10EIP3AACTIB
STARCH, CORNO8232NY3SJIACT
PETROLATUM4T6H12BN9UACTIB
7-DEHYDROCHOLESTEROLBK1IU07GKFIACT
LEVOMENOL24WE03BX2TIACT
SAFFLOWER OIL65UEH262ISIACT
DIMETHICONE92RU3N3Y1OIACT
CLOVEK48IKT5321IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-01-29full-release2026-06-01 00:07:59

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClobezinCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDESkya Health, LLC94bab0bd-c0b7-42f5-9e3c-911408817aed2025-12-19Warnings, Adverse reactionsExact identifier
ndc (package): 53329-156-83
ndc11 (package): 53329015683
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
ndc (package): 53329-156-83
ndc (package): 53329-156-14
ndc (package): 53329-156-96
ndc (package): 53329-156-44
ndc (product): 53329-156
ndc11 (package): 53329015614
ndc11 (package): 53329015683
ndc11 (package): 53329015644
ndc11 (package): 53329015696
spl id: 4161a6b2-cc86-f208-e063-6294a90ad120
spl set id: 006539c9-1982-d6de-e063-6294a90a1a5a

Reported adverse events (FAERS/openFDA)#

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