![SUNMARK HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [MCKESSON]](https://medic.hrt.org//dailymed/images/96272510-a5ac-45eb-b693-4ccd1df85405/18816S1C3.jpg)
| NDC | 49348-198-78 |
| Set ID | 96272510-a5ac-45eb-b693-4ccd1df85405 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Strategic Sourcing Services LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART346 |
- Active ingredients
- Purposes
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Uses
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- helps relieve the local itching and discomfort associated with hemorrhoids
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- temporarily shrinks hemorrhoidal tissue and relieves burning
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- temporarily provides a coating for relief of anorectal discomforts
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- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For external and/or intrarectal use only
Ask a doctor before use if you have
- •
- heart disease
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- high blood pressure
- •
- thyroid disease
- •
- diabetes
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- 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.
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Directions
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- 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.
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- when first opening the tube, puncture foil seal with top end of cap
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- apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
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- 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
SUNMARK HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-198 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:49348-198-78 1 in 1 CARTON 07/25/2016 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 07/25/2016 Labeler - Strategic Sourcing Services LLC (116956644)
