Lucky SuperSoft

Manufacturer
Delta Brands Inc
Effective date
2023-09-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:20

Label at a glance#

ProductLucky SuperSoft Hemorrhoidal
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

■ helps relieve local itching and discomfort associated with hemorrhoids ■ temporarily shrinks hemorrhoidal tissue and relieves burning ■ temporarily provides a coating for relief of anorectal discomforts ■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

■ adults: when practical cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying ointment ■ apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement ■ also apply ointment to external area ■ regular use provides continual therapy for relief of symptoms ■ ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Protectant

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

■ helps relieve local itching and discomfort associated with hemorrhoids ■ temporarily shrinks hemorrhoidal tissue and relieves burning

■ temporarily provides a coating for relief of anorectal discomforts ■ temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WARNINGS SECTION

For external and/or intrarectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ bleeding occurs ■ condition worsens or does not improve within 7 days ■ introduction of applicator into rectum causes additional pain

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use

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 by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying ointment ■ apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement ■ also apply ointment to external area ■ regular use provides continual therapy for relief of symptoms ■ children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

■ store at 20 to 25C (68-77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
20276-01720276-017-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
04cad7af-ae03-d00c-e063-6294a90a290fb674d156-4c1a-4798-e053-2995a90a50cf2023-09-07WarningsExact identifier
spl id: 04cad7af-ae03-d00c-e063-6294a90a290f
spl set id: b674d156-4c1a-4798-e053-2995a90a50cf

Reported adverse events (FAERS/openFDA)#

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