FDA Label for Rexall Hemorrhoidal Cooling
View Indications, Usage & Precautions
Rexall Hemorrhoidal Cooling 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.
Active Ingredients
Phenylephrine Hydrochloride 0.25%
Witch Hazel 50%
Purpose
Vasoconstrictor
Astringent
Uses
- temporary relieves irritation and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
Warnings
For external use only
Otc - Ask Doctor
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.
Otc - When Using
When using this product
- do not exceed the recommended daily dosage
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
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 gel
- 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
aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)
Principal Display Panel - 26 G Carton Label
REXALL HEMORRHOIDAL COOLING GEL
NET WT .9 OZ (26 g)
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