Label: HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 0536-1288-06
- Packager: Rugby
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- 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
- Stop Use and Ask Doctor if
- If Pregnant or breast-feeding
- Keep out of reach of children
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Directions
- Children under 12 years of age; ask doctor before use
- Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe.
Gently dry by patting or blotting with a tissue or soft cloth before applying.
- When first opening tube, remove foil seal
- Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
- Regular use provides continual therapy for relief of symptoms
- also apply ointment to external area.
- Other Information
- Inactive Ingredients
- Distributed by:
- Questions or Comments?
- Packaging
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1288 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 100 g MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 14 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g Inactive Ingredients Ingredient Name Strength STEARYL ALCOHOL (UNII: 2KR89I4H1Y) BENZOIC ACID (UNII: 8SKN0B0MIM) CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-23 (UNII: N72LMW566G) METHYLPARABEN (UNII: A2I8C7HI9T) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-1288-06 1 in 1 BOX 05/14/2020 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 Drug M015 05/14/2020 Labeler - Rugby (079246066) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
