NDC | 67091-278-57 |
Set ID | 04ca3ef1-fc6b-4683-b236-a75afc031fb5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Winco Foods, LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
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ACTIVE INGREDIENT
Active Ingredients (in each gram) Purpose
Mineral oil 14% --------------------------------------------------------------------- Protectant
Petrolatum 74.9%------------------------------------------------------------------- Protectant
Phenylephrine hydrochloride 0.25% ----------------------------------------------- Vasoconstrictor
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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 or anorectal discomforts
- temporarily portects the inflamed, irritated anorectal surface to help make bowel movements less painful
- WARNINGS
- ASK DOCTOR
- WHEN USING
- DO NOT USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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 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
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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WINCO HEMORRHOIDAL
mineral oil, petrolatum, and phenylephrine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-278 Route of Administration TOPICAL 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 1 g Inactive Ingredients Ingredient Name Strength 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) WHITE WAX (UNII: 7G1J5DA97F) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-278-57 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 01/29/2015 Labeler - Winco Foods, LLC (056098817)