Inactive Ingredient
Inactive Ingredients - beeswax, benzoic acid, cetyl alcohol, glycerin,
laureth - 23, methylparaben, propylparaben, stearyl alcohol
Family Wellness Ointment
FDA Label NDC 55621-006
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 Family Wellness (NDC 55621-006). 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, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients (in each gram)
Mineral oil 14 %
Petrolatum 74.9 %
Phenylephrine HCI 0,25 %
Otc - Purpose
Purposes
--- Protectant
---Protectant
---Vasoconstrictor
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
Warnings
Warnings
For external and/or intrarectal use only
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 due to high blood pressure
Otc - Stop Use
Stop use and ask a doctor if
-bleeding occurs
-condition worsens or does not improve within 7 days.
-Introduction of the appllicator into the rectum causes additional pain
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
Dosage & Administration
Directions
Adults and children 12 years of age and older for topical use:
-clean the affected area, and pat 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.
Storage And Handling
Other information - store at room temperature 68 - 77 F (20 - 25 C).
Otc - Questions
Questions? - 1-800-639-3803 Weekdays 9 AM to 4 PM EST
Package Label.Principal Display Panel
Copy Of Label (Zhejiang Hemalabelt)
* Please review the disclaimer below.
