Label: QUALITY CHOICE HEMORRHOIDAL- mineral oil ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63868-580-57 - Packager: Chain Drug Marketing Association
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 18, 2020
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- ACTIVE INGREDIENT
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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 of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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, peel back 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
- children under 12 years of age: ask a doctor
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE HEMORRHOIDAL
mineral oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-580 Route of Administration TOPICAL, RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) ALCOHOL (UNII: 3K9958V90M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) THYME OIL (UNII: 2UK410MY6B) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-580-57 1 in 1 CARTON 01/07/2020 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 06/30/2013 Labeler - Chain Drug Marketing Association (011920774)