![MAJOR PREP HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MAJOR PHARMACEUTICALS]](https://medic.hrt.org//dailymed/images/11d2b2b0-85b5-4a66-9ddb-73944cb3591a/188-5c-hemorrhoidal-ointment.jpg)
| NDC | 0904-6726-02 |
| Set ID | 11d2b2b0-85b5-4a66-9ddb-73944cb3591a |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Major Pharmaceuticals |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART346 |
- Active ingredients
- Purposes
-
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
- •
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
- Keep out of reach of children.
-
Directions
- •
- 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 ointment.
- •
- when first opening the tube, puncture foil seal with top end of cap
- •
- apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- •
- intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
- •
- also apply ointment to external area
- •
- regular use provides continual therapy for relief of symptoms
- •
- children under 12 years of age: ask a doctor
- Inactive ingredients
- Package/Label Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MAJOR PREP HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6726 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE .25 g in 100 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) THYME OIL (UNII: 2UK410MY6B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color YELLOW (light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-6726-02 1 in 1 CARTON 09/06/2018 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 09/06/2018 Labeler - Major Pharmaceuticals (191427277)
