Lucky SuperSoft by Delta Brands Inc LuckyhemorrhoidalOntmnt

Drug Details [pdf]

LUCKY SUPERSOFT HEMORRHOIDAL- mineral oil petrolatum phenylephrine hcl ointment
Delta Brands Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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LuckyhemorrhoidalOntmnt

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Vasoconstrictor

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

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

■ 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

presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

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

If pregnant or breastfeeding

ask a doctor before use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

■ 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

■ 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

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

LUCKY SUPERSOFT HEMORRHOIDAL
mineral oil petrolatum phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	14 g in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	74.9 g in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THYME OIL (UNII: 2UK410MY6B)
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 20276-017-42	42.5 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M015	01/31/2015

Labeler - Delta Brands Inc (102672008)

Revised: 9/2023

Document Id: 04cad7af-ae03-d00c-e063-6294a90a290f

Set id: b674d156-4c1a-4798-e053-2995a90a50cf

Version: 2

Effective Time: 20230907