![7 SELECT HEMORRHOIDAL ORIGINAL STRENGTH (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCL) OINTMENT [7-ELEVEN, INC.]](https://medic.hrt.org//dailymed/images/274f37cc-53be-453a-a595-b4d6fc2ed12c/PA 58852.01 PL 7-S OM Preparation H Ointment 0.7oz.jpg)
| NDC | 10202-526-20 |
| Set ID | 274f37cc-53be-453a-a595-b4d6fc2ed12c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | 7-ELEVEN, INC. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART346 |
- ACTIVE INGREDIENT
Active ingredients Purpose
Mineral oil 14%......................................................Protectant
Petrolatum 74.9%..................................................Protectant
Phenylephrine HCl 0.25%.......................................Vasoconstrictor
Close - PURPOSE
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
- ASK DOCTOR
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 DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Close - WHEN USING
When using this product do not exceed the recommended daily dosage unless directed by a doctor.
Close - STOP USE
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- introduction of applicator into the rectum causes additional pain
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Close - INDICATIONS & USAGE
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, remove foil seal
- apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- STORAGE AND HANDLING
Other information
- store at 20-25°C (68-77°F)
- lot no. & exp. date: see box or see crimp of tube
- INACTIVE INGREDIENT
Inactive ingredients
ethanol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax
Close - DOSAGE & ADMINISTRATION
- INGREDIENTS AND APPEARANCE
7 SELECT HEMORRHOIDAL ORIGINAL STRENGTH
mineral oil, petrolatum, and phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-526 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) 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:10202-526-20 1 in 1 BOX 12/07/2016 1 20 g in 1 TUBE, WITH APPLICATOR; 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 12/07/2016 CloseLabeler - 7-ELEVEN, INC. (007347602)