FDA.reportPublic FDA data

Hemorrhoidal Relief Cream

Manufacturer
Cardinal Health | Melaleuca, Inc.
Effective date
2023-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:38:52

Label at a glance#

ProductHemorrhoidal Relief Cream
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders.

WARNINGS SECTION

For External Use Only

Allergy Alert- Certain persons can develop allergic reactions to ingredients in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • retal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain, or other symptoms begin or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
  • Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

OTHER SAFETY INFORMATION

  • Store at 20-25 0C (68-77 oF)
  • to secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.

OTC - QUESTIONS SECTION

Questions & Comments? 516-444-5749

OTC - PURPOSE SECTION

Local Anesthetic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBoxTubeTube

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0468-1GM - Gram70000-046832a2cd83-2453-4341-a8db-bc54cc2fefdc12020-08-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-046870000-0468-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GRAPE6X543N684KIACT

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
f34200f3-289c-6a0c-e053-2a95a90a9156902f2390-d662-526d-e053-2995a90a79052023-01-27WarningsExact identifier
spl id: f34200f3-289c-6a0c-e053-2a95a90a9156
spl set id: 902f2390-d662-526d-e053-2995a90a7905

Reported adverse events (FAERS/openFDA)#

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