HemAway Maximum Strength Hemorrhoid Relief Cream

Manufacturer
Melaleuca, Inc.
Effective date
2025-03-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:48

Label at a glance#

ProductHemAway
Active ingredientLIDOCAINE
Label structure14 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.
  • 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.

OTC - QUESTIONS SECTION

Other information

  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • Tamper-Evident: do not use if foil seal under cap is broken or missing.
  • See crimp of tube for lot number and expiration date.

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine 5%

OTC - PURPOSE SECTION

Local anesthetic

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 right away.

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 - STOP USE SECTION

Stop use and ask a Doctor if:

  • Rectal bleeding occurs
  • Conditions worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Symptoms clear up and return in a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a Doctor or Pharmacist if you are: Presently taking a prescription drug for high blood pressure or depression.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding ask a health professional before use.

OTC - WHEN USING SECTION

When using this product:

  • 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HemAway MaxStrength Box.jpgHemAway MaxStrength Box.jpg

HenAway MaxStregnth Tube.jpgHenAway MaxStregnth Tube.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN3
1366789lidocaine 50 MG/ML Rectal CreamSCD3
1366789lidocaine 5 % Rectal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-336-02HemAway1 in 1 BOXCREAM13
54473-336-31HemAway30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-336HEMAWAY (LIDOCAINE) CREAM [MELALEUCA, INC.]3Current NDC, Legacy NDC, 2 package rows20250409_cf842adf-fcd7-2c8c-e053-2995a90adea6.zip

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
54473-33654473-336-31, 54473-336-02

Ingredients#

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

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

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
HemAwayLIDOCAINEMelaleuca, Inc.cf842adf-fcd7-2c8c-e053-2995a90adea62025-03-27WarningsExact identifier
ndc (package): 54473-336-31
ndc (package): 54473-336-02
ndc (product): 54473-336
ndc11 (package): 54473033602
ndc11 (package): 54473033631
spl id: 315a0b74-9363-a429-e063-6394a90adc0d
spl set id: cf842adf-fcd7-2c8c-e053-2995a90adea6

Reported adverse events (FAERS/openFDA)#

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