MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE

Dosage form: cream
Ingredients: MINERAL OIL 466mg in 1g, PRAMOXINE HYDROCHLORIDE 10mg in 1g, ZINC OXIDE 125mg in 1g
Labeler: CVS Pharmacy
NDC Code: 59779-399

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 facts

Active ingredients                                 Purpose

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

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. If swallowed, get medical help or contact
a Poison Control Center right away.

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

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


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 Ingredients

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



MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE 
mineral oil, pramoxine hydrochloride and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-399
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL466 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE125 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER 
GLYCERYL MONOSTEARATE 
GLYCERYL MONOOLEATE 
KAOLIN 
BALSAM PERU 
BENZYL BENZOATE 
CALCIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:59779-399-031 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
128 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/16/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 07/2010
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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