FDA Label for Family Wellness
View Indications, Usage & Precautions
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.
Otc - Active Ingredient
Active ingredients (in each gram)
Glycerin 14.4%
Phenylephrine HCL 0.25%
Pramoxine HCL 1%
White petrolatum 15%
Otc - Purpose
Purpose
Protectant
Vasoconstrictor
Local anesthetic
Protectant
Indications & Usage
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- 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 use only.
When using this product
-do not put this product into the rectum by using fingers or any mechanical device or applicator
-do not exceed recommended daily dosage unless directed by a 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
Ask a doctor or pharmacist before use if you are presently taking a prescription
drug for high blood pressure.
Stop use and ask a doctor if
-bleeding occurs -condition worsens or does not improve within 7 days.
-if the symptoms being treated do not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase. Some people can develop allergic
reactions to ingredients in this product.
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:
-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 a soft
cloth before application of this product.
-apply externally to the affected area up to 4 times daily, especially at night or
in the morningor after each bowel movement.
Children under 12 years of age: consult a doctor.
Storage And Handling
Other information store at room temperature 68 - 77 F(20 - 25 C).
Inactive Ingredient
Inactive ingredients aloe barbadensis leaf extract,
carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,
methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,
water, xanthan gum
Package Label.Principal Display Panel
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