MAJOR PREP HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hydrochloride ointment 
Major Pharmaceuticals

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.

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Drug Facts

Active ingredients                                                               Purpose

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

Petrolatum 71.9%............................................................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 or a pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

When using this product do not use more than 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

image of carton label
MAJOR PREP HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6319
Route of AdministrationTOPICAL, RECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYME OIL (UNII: 2UK410MY6B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6319-021 in 1 CARTON06/30/201310/03/2016
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/30/201310/03/2016
Labeler - Major Pharmaceuticals (191427277)
Registrant - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Major Pharmaceuticals191427277REPACK(0904-6319)

Revised: 8/2018
 
Major Pharmaceuticals