MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE cream

MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE by

Drug Labeling and Warnings

MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                 Purpose

Mineral Oil 46.8%.............................................Protectant
Pramoxine HCL 1%......................................... Pain Reliever
Zinc Oxide 12.5%............................................Protectant

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

Keep out of reach of children. If swallowed, get medical help or contact
a 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 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

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

Inactive Ingredients

benzyl benzonate, dicalcium phosphate, glyceryl oleate, glyceryl stearate,
kaolin, peruvian balsam, polyethylene, theobroma cacao (cocoa) seed butter

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE 
mineral oil, pramoxine hydrochloride and zinc oxide cream

Product 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