FDA Label for Rexall Hemorrhoidal
View Indications, Usage & Precautions
Rexall Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Dolegencorp,llc. 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Glycerin 14.4% | Anorectal (Hemorrhoidal) Cream |
| Petrolatum 15% | Anorectal (Hemorrhoidal) Cream |
| Phenylephrine HCl 0.25% | Anorectal (Hemorrhoidal) Cream |
| Pramoxine HCl 1% | Anorectal (Hemorrhoidal) Cream |
Uses
- Temporarily relieves itching and discomfort associated with hemorrhoids.
- Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.
- Temporarily shrinks hemorrhoidal tissue
- Temporarily forms a protective coating over inflamed tissues to help prevent dryness.
- Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
Not for prolonged use.
Otc - Do Not Use
Do not use in the eyes or nose.
Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
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 apply to large areas of the body
- do not exceed the recommended daily dosage unless directed by a doctor
- do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
Otc - Stop Use
Stop use and ask a physician if
- bleeding occurs
- the condition worsens or does not improve within 7 days
- an allergic reaction develops
- the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increases.
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: 800-222-1222.
Directions
- Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream
- apply externally to the affected area up to 4 times daily or after each bowel movement
- FOR INTRARECTAL USE: Remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, and then gently insert the dispensing cap into the rectum.
- thoroughly cleanse dispensing cap after each use, and replace the cover
- children under 12 years old: consult a physician
Other Information
- Store at 15 to 30°C (59 to 86°F)
- Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
Inactive Ingredients
Aloe barbadensis leaf juice, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum
Principal Display Panel - 28 G Tube Carton
NDC 55910-331-24
Since 1903
Rexall®
MAXIMUM STRENGTH
Hemorrhoidal Cream
- Rapid, soothing pain relief from burning, itching and discomfort
- Protects irritated tissue
NET WT 1 OZ (28 g)
* Please review the disclaimer below.