Inactive Ingredient
Inactive Ingredients beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol
Theraplus Ointment
FDA Label NDC 55621-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhejiang Jingwei Pharmaceutical Co., Ltd. for the product Theraplus (NDC 55621-005). 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 inactive ingredient, otc - active ingredient, warnings, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient (in each gram)
Mineral oil 14%
Petrolatum 74.9%
Phenylephrine HCI 0.25%
Warnings
For external and/or intrarectal use only
Otc - Purpose
Purpose
Protectant
Protectant
Vasoconstrictor
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses
-helps relieve the local itching and discomfort associated with hemorrhoids
-temporarily shrinks hemorrhoid 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 & Administration
Directions
adults and children 12 years of age and older for topical use:
-clean the affected area, and oat or dab dry before applying ointment
-apply to the affected area up to 4 times daily, especially after each bowel movement
for intrarectal use:
-attach included applicator to tube
-lubricate applicator tip and gently insert into rectum
-thoroughly clean applicator after each use, and replace cover
children under 12 years of age: ask a doctor before use
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use
Otc - Stop Use
Stop use and ask a doctor if
-bleeding occurs
-condition worsens or does not improve within 7 days
-introduction of the applicator into the rectum causes additional pain
Otc - Ask Doctor
Ask a doctor before use if you have
-heart disease
-high blood pressure
-thyroid disease
-diabetes
-trouble urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are
-presently taking a prescription drug for high blood pressure
Package Label.Principal Display Panel
Copy Of Label (Zhejiang Hemo)
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