Label: MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL ointment
Contains inactivated NDC Code(s)
NDC Code(s): 50730-4536-0
- Packager: H and P Industries, Inc. dba Triad Group
- 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 November 20, 2009
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- ACTIVE INGREDIENTS
For external and/or intrarectal use only.
Ask a doctor before use if you have
- heart disease
- thyroid disease
- high blood pressure
- 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.
When using this product
- do not exceed the recommended daily dosage.
- do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.
Stop use and ask a doctor if
- you experience bleeding
- condition worsens or does not improve within 7 days.
- When practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this ointment.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Before applying, remove protective cover from applicator. Attach applicator to tube. Lubricate applicator well and then gently insert applicator into the rectum. Thoroughly clean applicator after each use and replace protective cover.
- Also apply ointment to external area.
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENTS
Helps prevent further irritation
Temporarily shrinks hemorrhoids
- Soothes itching, burning and discomfort associated with hemorrhoids
- Temporarily shrinks hemorrhoids
- For prompt temporary relief
2 oz. (56.7 g)
Triad Group, Inc.
Brookfield, WI 53045
MADE IN USA
DO NOT USE IF SEAL UNDER CAP OF TUBE IS BROKEN OR MISSING WHEN PURCHASED.
INGREDIENTS AND APPEARANCE
MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, SHARK LIVER OIL
mineral oil, petrolatum, phenylephrine hydrochloride, shark liver oil ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50730-4536 Route of Administration RECTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength light mineral oil (UNII: N6K5787QVP) (light mineral oil - UNII:N6K5787QVP) light 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 WAX, YELLOW (UNII: 2ZA36H0S2V) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) THYMUS OIL (UNII: M86Z5G7U0L) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50730-4536-0 1 in 1 BOX 1 56.7 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/01/2005 Labeler - H and P Industries, Inc. dba Triad Group (050259597) Registrant - H and P Industries, Inc. dba Triad Group (050259597) Establishment Name Address ID/FEI Business Operations H and P Industries, Inc. dba Triad Group 050259597 manufacture