Label: FAMILY CARE HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-009-20 - Packager: UNITED EXCHANGE CORP.
- 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 March 1, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Mineral oil 14% .................................................................Protectant
Petrolatum 71.9% .............................................................Protectant
Phenylephrine HCL 0.25% .................................................Vasoconstrictor
Shark liver oil 3.0% ...........................................................Protectant
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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
- children under 12 years of age: ask a doctor
- 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
- when first opening tube, remove foil seal
- for intrarectal use: remove protective cover form applicator and attach to
tube
- lubricate applicator well, then gently insert applicator into the rectum
- thoroughly clean applicator and replace protective cover after each use
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- also apply ointment to external area
- 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 CARE HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl, shark liver oil ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-009 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 PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 719 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g SHARK LIVER OIL (UNII: 4B24275HEU) (SHARK LIVER OIL - UNII:4B24275HEU) SHARK LIVER OIL 30 mg in 1 g Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) LANOLIN (UNII: 7EV65EAW6H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-009-20 1 in 1 CARTON 1 20 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 03/01/2012 Labeler - UNITED EXCHANGE CORP. (840130579)