Label: MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-399-03 - Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
Drug Label Information
Updated July 16, 2010
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- ACTIVE INGREDIENT
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PURPOSE
Active ingredients Purpose
Mineral Oil 46.8%.............................................Protectant
Pramoxine HCL 1%......................................... Pain Reliever
Zinc Oxide 12.5%............................................Protectant
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
- KEEP OUT OF REACH OF CHILDREN
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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)
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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 applicator
Stop 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 days
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away
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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 use
Children under 12 years of age: ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE
mineral oil, pramoxine hydrochloride and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-399 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 466 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 125 mg in 1 g Inactive Ingredients Ingredient Name Strength COCOA BUTTER (UNII: 512OYT1CRR) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL MONOOLEATE (UNII: 4PC054V79P) KAOLIN (UNII: 24H4NWX5CO) BALSAM PERU (UNII: 8P5F881OCY) BENZYL BENZOATE (UNII: N863NB338G) CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-399-03 1 in 1 CARTON 1 28 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/16/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture
