Label: FAMILY WELLNESS HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hcl ointment
- NDC Code(s): 55319-381-56
- Packager: Family Dollar Services, Inc
- Category: HUMAN OTC DRUG LABEL
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 September 25, 2023
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ACTIVE INGREDIENT
Drug Facts
Active ingredients Purposes
Mineral oil 14.0%.....................................................................Skin protectant
Petrolatum 74.9%....................................................................Skin protectant
Phenylephrine HCI 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 of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- 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
- FOR INTRARECTAL USE: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into rectum. Thoroughly clean applicator after each use and replace cover. Also apply ointment to external area.
- regular use provides continue 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
FAMILY WELLNESS HEMORRHOIDAL
mineral oil, petrolatum, and phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-381 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 1 g 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 Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) THYME OIL (UNII: 2UK410MY6B) WHITE WAX (UNII: 7G1J5DA97F) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALCOHOL (UNII: 3K9958V90M) LANOLIN (UNII: 7EV65EAW6H) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-381-56 1 in 1 CARTON 09/18/2023 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 M015 09/18/2023 Labeler - Family Dollar Services, Inc (024472631)