Label: MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL- mineral oil, petrolatum, phenylephrine hcl ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 49743-3047-1 - Packager: Axcentria Pharmaceuticals, LLC
- 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 28, 2013
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSES
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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
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WARNINGS
For external and/or intrarectal use only
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
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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, 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
- children under 12 years of age: ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
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PRINCIPAL DISPLAY PANEL - 56.8 g Tube Carton
HEMORRHOIDAL
OINTMENTTAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.
- Prompt, Soothing Relief from painful burning, itching and discomfort
- Shrinks swollen hemorrhoidal tissue
- Protects irritated tissue
- Relieves internal and external discomfort
NET WT 2 OZ (56.8 g)
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INGREDIENTS AND APPEARANCE
MINERAL OIL, PETROLATUM AND PHENYLEPHRINE HCL
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49743-3047 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 741 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SHARK LIVER OIL (UNII: 4B24275HEU) THYME (UNII: CW657OBU4N) TOCOPHEROL (UNII: R0ZB2556P8) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color YELLOW (smooth yellow ointment) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49743-3047-1 1 in 1 CARTON 1 56.8 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part346 06/28/2013 Labeler - Axcentria Pharmaceuticals, LLC (961871501) Establishment Name Address ID/FEI Business Operations Axcentria Pharmaceuticals, LLC 961871501 ANALYSIS(49743-3047) , MANUFACTURE(49743-3047)