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  5. Label Information: Rexall Maximum Strength Hemorrhoidal

FDA Label for Rexall Maximum Strength Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. OTHER
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rexall Maximum Strength Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Dolgencorp, 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.

Otc - Active Ingredient



Active ingredients  
Glycerin 14.4%
Petrolatum 15%
Phenylephrine Hydrochloride 0.25%
Pramoxine HCl 1%


Otc - Purpose



Purpose

Protectant
Protectant
Vasoconstrictor
Local anesthetic


Indications & Usage



Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporary relieves burning
  • aid in protecting irritated anorectal areas

Warnings



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

    • 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 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.


Dosage & Administration



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



Other information

  • store at 20°- 25°C (68°- 77°F)
  • for lot number and expiration date, see crimp of tube or see box

Inactive Ingredient



Inactive ingredients

aloe barbadensis leaf, cetearyl alcohol, cetyl alcohol, glycerol monostearate,  mineral oil, peg 40 castor oil, propylene glycol, purified water, 
stearyl alcohol, tocopheryl acetate (Vitamin E).


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

REXALL MAXIMUM STRENGTH HEMORRHOIDAL

NET WT 1 OZ (28 g)

label of rexall - rexall hemorrhoidal

label of rexall - rexall hemorrhoidal


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