ANESTHETIC HEMORRHOIDAL WITH ALOE- pramoxine hydrochloride, zinc oxide ointment

Anesthetic Hemorrhoidal by

Drug Labeling and Warnings

Anesthetic Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, Inc., Anicare Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

ANESTHETIC HEMORRHOIDAL  WITH ALOE
pramoxine hydrochloride, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-2438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	420 mg  in 42 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.25 g  in 42 g

Inactive Ingredients
Ingredient Name	Strength
BALSAM PERU (UNII: 8P5F881OCY)
BENZYL BENZOATE (UNII: N863NB338G)
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX)
COCOA BUTTER (UNII: 512OYT1CRR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
KAOLIN (UNII: 24H4NWX5CO)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL OLEATE (UNII: 4PC054V79P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29500-2438-1	42 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	07/10/2013

Labeler - Personal Care Products, Inc. (966155082)

Registrant - Personal Care Products, Inc. (966155082)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd.		916837425	manufacture(29500-2438)