Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-044-02 - Packager: Geritrex LLC
- 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 July 31, 2015
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- Official Label (Printer Friendly)
- Active Ingredient PurposeMineral Oil - 14% ProtectantPetrolatum - 71.9% ProtectantPhenylephrine - 0.25% Astringent
- PURPOSE
- Uses:
- Warnings:
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- When using this product:
- Stop use and ask a doctor if:
- If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- If swallowed get medical help or contact a poison control center right away.
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Directions:
- Adults: 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 a soft cloth before application of this ointment
- Apply to 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 into the rectum.
- Thoroughly cleanse applicator after each use
- Also apply ointment to external area
- Regular use provides continual therapy for relief of symptoms
- Children under 12 years of age, consult a doctor
- Other Information:
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-044 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 7.98 g in 57 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 40.983 g in 57 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.1425 g in 57 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) SHARK LIVER OIL (UNII: 4B24275HEU) THYME (UNII: CW657OBU4N) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-044-02 57 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/31/2015 Labeler - Geritrex LLC (112796248) Establishment Name Address ID/FEI Business Operations Geritrex LLC 112796248 manufacture(54162-044)