Active Ingredients
Lidocaine 5%
Phenylephrine HCL 0.25%
Hemorrhoid And Fissure Cream With Lidocaine 5% Plus Phenylephrine Hcl 0.25% Cream
FDA Label NDC 73715-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mohnark Pharmaceuticals Inc for the product Hemorrhoid And Fissure Cream With Lidocaine 5% Plus Phenylephrine Hcl 0.25% (NDC 73715-007). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Vasoconstrictor
Warnings
For external use only
When Using This Product
When using this product
• avoid contact with eyes
• do not exceed recommended
dosage unless directed by a doctor
• do not put this product into the
rectum by using fingers or any
mechanical device or applicato
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
• rectal bleeding occurs
• condition worsens or does not
improve within 7 days
• allergic reaction occurs
• symptom being treated does not
subside or if redness, irritation,
swelling, pain or other symptoms
develop or increase
• symptoms clear up and return within
a few days
Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center.
Directions
• 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 soft cloth before applying.
• Adults and children 12 years and older: apply externally to the affected
area up to 6 times a day.
• Children under 12 years of age: consult a doctor.
Other Information
• Store at USP controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients
benzyl alcohol, carbomer 940, aloe
barbadensis leaf extract, cholesterol,
hydrogenated lecithin, polysorbate 80,
propylene glycol, tocopheryl acetate,
trolamine, water.
Uses
- temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders
- for the temporary relief of pain, soreness or burning
- temporarily reduces the swelling associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders
for the temporary relief of pain, soreness or burning
temporarily reduces the swelling associated with hemorrhoids
temporarily shrinks hemorrhoidal tissue
Dosage And Administration
adults, when practical, cleanse the affected area by pattig or blotting with an appropriate cleansing pad
gently dry by patting or blotting with toie tissue or soft cloth before application of this product
apply externally to the affected area up to 4 times daily
chidren under 12 years of age, consult a doctor
Package Label.Principal Display Panel
Lidocaine 5% Plus Phcl 0.25% (Fda Panel2)
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