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Major Prep Hemorrhoidal by Major Pharmaceuticals

Medically reviewed on October 11, 2016

Dosage form: ointment
Ingredients: MINERAL OIL 140mg in 1g, PETROLATUM 749mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-6356

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.

Active ingredients                                                               Purpose

Mineral oil 14%................................................................Protectant

Petrolatum 74.9%............................................................Protectant

Phenylephrine HCl 0.25%..........................................Vasoconstrictor

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieves burning
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings For external and/or intrarectal use only

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Ask a doctor of pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

When using this product do not exceed the recommended daily dosage

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not get better within 7 days
  • introduction of the applicator into the rectum causes additional pain

If pregnant or breast-feeding, ask a physician before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • children under 12 years of age: ask a doctor
  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
  • gently dry by patting or blotting with a tissue or a soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator and attach to tube
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area

Other information store at 20° to 25°C (68° to 77°F)

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Distributed By

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150

Made in Korea

MAJOR PREP HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6356
Route of AdministrationRECTAL, TOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL140 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
LANOLIN 
METHYLPARABEN 
PROPYLPARABEN 
STEARYL ALCOHOL 
THYME OIL 
TOCOPHEROL 
WATER 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:0904-6356-021 TUBE in 1 CARTON
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34606/03/2014
Labeler - Major Pharmaceuticals (191427277)

 
Major Pharmaceuticals

← See all Major Prep Hemorrhoidal brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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