FDA Label for Hemorrhoidal Pain Relief With Aloe And Vitamine
View Indications, Usage & Precautions
- DRUG FACTS - ACTIVE INGREDIENTS
- PURPOSE
- USES:
- WARNINGS:
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE
- WHEN USING THIS PRODUCT:
- STOP USE AND ASK DOCTOR IF:
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS?
- TAMPER EVIDENT:
- IMPORTANT
- USE
- PACKAGE LABEL _OUTER CARTON
Hemorrhoidal Pain Relief With Aloe And Vitamine Product Label
The following document was submitted to the FDA by the labeler of this product Neilmed Pharmaceuticals 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.
Drug Facts - Active Ingredients
Glycerin 14.4%
Phenylephrine Hydrochloride 0.25%
Pramoxine Hydrochloride 1%
White petrolatum 15%
Purpose
Glycerin 14.4% ..................................................................... Protectant
Phenylephrine Hydrochloride 0.25% ...............................Vasoconstrictor
Pramoxine Hydrochloride 1% ...................................... Local Anesthetic
White petrolatum 15% .......................................................... Protectant
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:
For external use only
Ask A Doctor Before Use If You Have
��������Heart disease ��������High blood pressure ��������Thyroid disease ��������Diabetes��������Difficulty in urination due to enlargement of 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 in the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask Doctor If:
��������Bleeding occurs ��������Condition worsens or does not improve within 7 days ��������An allergic reaction occurs ��������The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions:
��������Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. ��������Gently dry by patting or blotting with a tissue or a soft cloth before applying cream. ��������When first opening the tube, puncture foil seal with top end of cap. ��������Apply externally or in the lower portion of the anal canal only. ��������Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. ��������For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing well, then gently insert dispensing cap partway into the anus. Thoroughly cleanse
dispensing cap after each use and replace cover. ��������Children under 12 years of age: ask a doctor.
Inactive Ingredients:
aloe barbadensis leaf extract, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, stearic acid, tocopherol acetate
Questions?
Questions? 1 (877) 477-8633
Tamper Evident:
TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
Important
Important: Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.
Use
swollen hemorrhoidal tissue, to get quick temporary relief from pain, burning, itching& irritation
Package Label _Outer Carton
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