LUCKY SUPERSOFT HEMORRHOIDAL- mineral oil petrolatum phenylephrine hcl ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP), PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Delta Brands Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Protectant Protectant Vasoconstrictor ■ 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 ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ difficulty in urination due to enlargement of prostate gland presently taking a prescription drug for high blood pressure or depression ■ bleeding occurs ■ condition worsens or does not improve within 7 days ■ introduction of applicator into rectum causes additional pain

Authorization status:

OTC monograph final

Summary of Product characteristics

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
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