Label: HEMORRHOIDAL- pain relief ointment
- NDC Code(s): 13709-319-01
- Packager: NeilMed Pharmaceuticals Inc.
- 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 August 22, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
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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.
- Warnings:
- Ask a doctor before use if you have:
- Ask a doctor or pharmacist before use
- When using this product:
- Stop use and ask doctor if:
- If pregnant or breast-feeding,
- Keep out of reach of children
-
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.
Regular use provides continual therapy for relief of symptoms.
Children under 12 years of age: ask a doctor.
- Other information:
- Inactive ingredients:
- TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
pain relief ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13709-319 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 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) LANOLIN (UNII: 7EV65EAW6H) BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) CORN OIL (UNII: 8470G57WFM) WHITE WAX (UNII: 7G1J5DA97F) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) THYME (UNII: CW657OBU4N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13709-319-01 1 in 1 CARTON 08/22/2023 1 57 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M015 08/22/2023 Labeler - NeilMed Pharmaceuticals Inc. (799295915) Establishment Name Address ID/FEI Business Operations NeilMed Pharmaceuticals Inc. 799295915 manufacture(13709-319)