Label: APJ HEMORRHOIDAL- phenylephrine hydrochloride, mineral oil, petrolatum ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 46084-111-10, 46084-111-20 - Packager: A P J Laboratories Limited
- 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 June 1, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
■ 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
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DOSAGE & ADMINISTRATION
■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, puncture foil seal with top end of cap
■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
- INACTIVE INGREDIENT
- DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
APJ HEMORRHOIDAL
phenylephrine hydrochloride, mineral oil, petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46084-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.55 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 720 mg in 1 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 1 g Inactive Ingredients Ingredient Name Strength PARAFFIN (UNII: I9O0E3H2ZE) 40 mg in 1 g BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 70 mg in 1 g METHYLPARABEN (UNII: A2I8C7HI9T) .1 mg in 1 g PROPYLPARABEN (UNII: Z8IX2SC1OH) .1 mg in 1 g CHLOROCRESOL (UNII: 36W53O7109) .02 mg in 1 g LANOLIN (UNII: 7EV65EAW6H) .5 mg in 1 g MAGNESIUM STEARATE (UNII: 70097M6I30) 1 mg in 1 g LIGHT MINERAL OIL (UNII: N6K5787QVP) 10 mg in 1 g Product Characteristics Color white (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46084-111-10 28 g in 1 TUBE 2 NDC:46084-111-20 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/01/2013 Labeler - A P J Laboratories Limited (677378339) Registrant - A P J Laboratories Limited (677378339) Establishment Name Address ID/FEI Business Operations A P J Laboratories Limited 677378339 manufacture(46084-111)
