FDA.reportPublic FDA data

Mayinglong Hemorrhoidal Ointment

Manufacturer
Mayinglong Pharmaceutical Group Co., Ltd.
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:47

Label at a glance#

ProductMayinglong Hemorrhoidal
Active ingredientPETROLATUM, ZINC OXIDE
Label structure9 sections

Indications and uses

For the temporary relieve of local itching and discomfort associated with hemorrhoids. 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 provides a coating for relief of anorectal discomforts. Temporarily protects the inflamed, irritated anor...

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of the ointment. Apply to the affected area up to 2 times daily or after each bowel movement. Apply liberally to the affected area. Attach applicator to tube. Lubricate applicator well with ointment, then gently insert applicator ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 77.99%

Calamine 7.6%

Purpose

OTC - PURPOSE SECTION

Protectant

Astringent

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relieve of local itching and discomfort associated with hemorrhoids.
  • 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 provides a coating for relief of anorectal discomforts.
  • 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.

Warnings

WARNINGS SECTION

For external use and/or intrarectal use only

Do not use

OTC - DO NOT USE SECTION

  • If allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

  • Do not exceed the recommended daily dosage unless as directed by a doctor.
  • Do not use the product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Bleeding occurs 
  • Condition worsens or does not improve within 7 days

Do not use during pregnancy or when breast feeding.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away Do not use otherwise than as directed.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of the ointment.
  • Apply to the affected area up to 2 times daily or after each bowel movement.
  • Apply liberally to the affected area.
  • Attach applicator to tube. Lubricate applicator well with ointment, then gently insert applicator into the rectum. FOR INTRARECTAL USE:
  • Children under 12 years of age: consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature, 10 ℃ to 30℃ (50℉ to 86℉)
  • Keep the container closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

Amber, Artificial bezoar (Bos Taurus Bile, Cholic Acid,D eoxycholic Acid, Taurine, Bilirubin, Cholesterol), Artificial musk (Muscone), Borax, Borneol, Dimethyl sulfoxide, Lanolin, Pear

Questions?

OTC - QUESTIONS SECTION

+1-888-915-6789 M-F 9am to 5pm Pacific Time You may report serious side effects to this phone number.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBottle2Bottle2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2396041petrolatum 77.99 % / zinc oxide 7.6 % Topical OintmentPSN3
2396041petrolatum 0.78 MG/MG / zinc oxide 0.076 MG/MG Topical OintmentSCD3
2396041petrolatum 0.78 MG/MG / ZNO 0.076 MG/MG Topical OintmentSY3
2396041petrolatum 77.99 % / zinc oxide 7.6 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
39cdeb64-f113-4e85-b7f0-4953949e9750Product name220211014
f99d8137-bd66-44a7-97c0-687c5d02cfc7Product name120150417
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68511-998-01Mayinglong Hemorrhoidal10 g in 1 TUBEOINTMENT103
68511-998-01Mayinglong Hemorrhoidal1 in 1 BOXOINTMENT13
68511-998-02Mayinglong Hemorrhoidal1 in 1 BOXOINTMENT13
68511-998-02Mayinglong Hemorrhoidal10 g in 1 TUBEOINTMENT103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68511-998MAYINGLONG HEMORRHOIDAL (PETROLATUM, ZINC OXIDE) OINTMENT [MAYINGLONG PHARMACEUTICAL GROUP CO., LTD.]3Current NDC, Legacy NDC, 4 package rows20231210_b14192ea-1bf7-da6a-e053-2a95a90a5b5e.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68511-99868511-998-01, 68511-998-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMBER70J9Z0J26PIACT
BOS TAURUS BILEET3651ZLOUIACT
CHOLIC ACIDG1JO7801AEIACT
DEOXYCHOLIC ACID005990WHZZIACT
TAURINE1EQV5MLY3DIACT
BILIRUBINRFM9X3LJ49IACT
CHOLESTEROL97C5T2UQ7JIACT
MUSCONEUPS3C6CV36IACT
SODIUM BORATE91MBZ8H3QOIACT
BORNEOLM89NIB437XIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
LANOLIN7EV65EAW6HIACT
PEARL (HYRIOPSIS CUMINGII)A75L5FZ40UIACT
PETROLATUM4T6H12BN9UACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
ndc (package): 68511-998-01
ndc (package): 68511-998-02
ndc (product): 68511-998
ndc11 (package): 68511099802
ndc11 (package): 68511099801
spl id: 0c0d598f-0e8d-46aa-e063-6394a90a90fc
spl set id: b14192ea-1bf7-da6a-e053-2a95a90a5b5e

Reported adverse events (FAERS/openFDA)#

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