Drug Facts Active Ingredient
Pramoxine HCL 1%
Zinc oxide 12.5%
Anesthetic Hemorrhoidal
FDA Label NDC 29500-2438
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Personal Care Products, Inc. for the product Anesthetic Hemorrhoidal (NDC 29500-2438). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts active ingredient, purpose, keep out of reach of children, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item That's smart wellness!
Distributed by: PERSONAL CARE PRODUCTS, LLC
Troy, Michigan 484084 U.S.A. Code No.MH/DRUGS/KD-313 Made in India
Pc Hemorrhodial1 Label (Pc Hemorrhodial1)
Pc Hemorrhodial4 Label (Pc Hemorrhodial4)
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