The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Mineral Oil, Pramoxine Hydrochloride And Zinc Oxide (NDC 59779-399). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredients PurposeMineral Oil 46.8%.............................................ProtectantPramoxine HCL 1%......................................... Pain RelieverZinc Oxide 12.5%............................................Protectant
Otc - Purpose
Active ingredients Purpose
Mineral Oil 46.8%.............................................Protectant
Pramoxine HCL 1%......................................... Pain Reliever
Zinc Oxide 12.5%............................................ProtectantUses- temporarily relieves these local symptoms associated with hemorrhoids and other anorectal disorders:- pain - soreness - burning - itching- temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contacta Poison Control Center right away.
Indications & Usage
Uses- temporarily relieves these local symptoms associated with hemorrhoids and other anorectal disorders:- pain - soreness - burning - itching- temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
Warnings
Warnings For external use only. When using this product - do not use more than directed unless told to do so by a doctor- do not put into rectum by using fingers or any mechanical device or applicatorStop use and ask a doctor if- allergic reaction occurs- rectal bleeding occurs- redness, irritation, swelling pain or other symptoms begin or increase- condition worsens, or does not improve within 7 daysKeep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions Adults: apply externally to the affected area up to 5 times daily- when practical, clean the affected area with mild soap and warn water and rinse thoroughly- gently dry by patting or blotting with toilet tissue or soft cloth before applying- to use dispensing cap: - attach it to tube, lubricate well, then gently insert partway into anus - squeeze tube to deliver medication - thoroughly cleanse dispensing cap after useChildren under 12 years of age: ask a doctor
Inactive Ingredient
Inactive Ingredientsbenzyl benzonate, dicalcium phosphate, glyceryl oleate, glyceryl stearate, kaolin, peruvian balsam, polyethylene, theobroma cacao (cocoa) seed butter
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