1. Home
  2. Labeler Index
  3. Zhejiang Jingwei Pharmaceutical Co., Ltd.
  4. 55621-006
  5. Label Information: Family Wellness

FDA Label for Family Wellness

View Indications, Usage & Precautions

Table of Contents

    1. INACTIVE INGREDIENT
    2. OTC - ACTIVE INGREDIENT
    3. OTC - PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Wellness 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 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

copy of label - Zhejiang HemalabelT


* Please review the disclaimer below.