FDA Label for Anesthetic Hemorrhoidal With Aloe
View Indications, Usage & Precautions
Anesthetic Hemorrhoidal With Aloe Product Label
The following document was submitted to the FDA by the labeler of this product Personal Care Products, 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 Ingredient
Pramoxine HCL 1%
Zinc oxide 12.5%
Purpose
Local anesthetic
Protectant
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.
Uses
temporarily shrinks hemorrhoidal tissue
temporarily relieves itching, burning and discomfort associated with hemorrhoids
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 the 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 use this product with an applicator, if the applicator into the rectum causes additional pain. Consult a doctor promptly.
Stop use and ask a doctor if - you experience bleeding, condition worsens or does not improve within 7 days, these may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Directions
Direction for adults
when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment, apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
Children under 12 years or age, ask a doctor.
Other Information
store between 59° and 86° F (15° and 30° C), close cap tightly after use, do not use if seal on tube is punctured or missing
Inactive Ingredients
balsam peru, benzyl benzoate, calcium phohsphate, cocoa butter, glyceryl monostearate, glyceryl monoleate, kaolin, mineral oil, Aloe vera extract
Product Label
DRUGSTORE - Rx
SMART WELLNESS
Anesthetic Hemorrhoidal Ointment With Aloe
Quick and soothing, pain relief from burning, itching and discomfort
Shrinks swollen hemorrhoidal tissue
NET WT. 1.5 OZ. (42 g)
DRUGSTORE-Rx
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Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 484084 U.S.A. Code No.MH/DRUGS/KD-313 Made in India
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