FDA Label for Select Brand Hemorrhoid
View Indications, Usage & Precautions
Select Brand Hemorrhoid Product Label
The following document was submitted to the FDA by the labeler of this product L&r Distributors, Inc.. 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.
Other
Drug Facts
Active Ingredients
Glycerin 14.4%
Petrolatum 15%
Phenylephrine HCl 0.25%
Pramoxine HCl 1%
Purposes
Protectant
Protectant
Vasoconstrictor
Local anesthetic
Uses
- helps relieve local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily relieves burning
- aids in protecting irritated anorectal areas
Warnings
For external use only
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- 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 or depression
When Using This Product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- bleeding occurs
- condition gets worse or does not improve within 7 days
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.
Directions
- Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying
- when first opening the tube, puncture foil seal with top end of cap
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- Children under 12 years of age: ask a doctor
Other Information
- store at 20°-25°C (68°-77°F)
- for lot number and expiration date, see crimp of tube or see box
Inactive Ingredients
cetearyl alcohol, cetyl alcohol, glycerol monostearate, mineral oil, peg 40 castor oil, propylene glycol, purified water, stearyl alcohol, tocopheryl acetate (Vitamin E)
Principal Display Panel - 1Oz Carton Label
NDC 15127-590-00
A medicated cream for local application as an aid
in the relief of the discomfort due to rectal irritation.
select brand®
the lower price name brand
HEMORRHOIDAL
CREAM
MAXIMUM STRENGTH
*Compare to the active ingredients in
Preparation H® Maximum Strength Cream
Net Wt. 1 oz (28g)
* Please review the disclaimer below.