MAJOR PREP HEMORRHOIDAL- mineral oil, petrolatum and 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

Warnings For external and/or intrarectal use only

Ask a doctor before use if you have

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6319
Route of Administration TOPICAL, RECTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 719 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:0904-6319-02 1 in 1 CARTON
1 57 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 06/30/2013
Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2013
Document Id: 2ad9974c-efd5-476b-bc11-c978c3400ed4
Set id: c4fbb058-fc1d-472e-9cee-69dd2598f5da
Version: 3
Effective Time: 20130630
 
Major Pharmaceuticals