Label: ANESTHETIC HEMORRHOIDAL WITH ALOE- pramoxine hydrochloride, zinc oxide ointment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 23, 2020
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- Drug Facts Active Ingredient
- Keep out of reach of children
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.
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
- Inactive ingredients
DRUGSTORE - Rx
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)
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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
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; Type 0: Not a Combination Product 06/01/2020 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)