FDA Label for Theraplus Plus
View Indications, Usage & Precautions
Theraplus Plus Product Label
The following document was submitted to the FDA by the labeler of this product Zhejiang Jingwei Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Inactive Ingredient
Inactive Ingredients beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23, methylparaben, propylparaben, stearyl alcohol
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
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