Label: HEMORRHOIDALOINTMENT- mineral oil, petrolatum, phenylephrine hci ointment
- NDC Code(s): 69396-083-01
- Packager: Trifecta Pharmaceuticals USA 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 January 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
-
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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
-
Warnings
For external and/or anorectal use only
Ask 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 doctor before use if you are presently taking a prescription drug for high blood pressure or depression
- 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.
- 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
- Other Information
- Packaging
-
INGREDIENTS AND APPEARANCE
HEMORRHOIDALOINTMENT
mineral oil, petrolatum, phenylephrine hci ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 74.9 g in 100 g 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 Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) LAURETH-23 (UNII: N72LMW566G) BENZOIC ACID (UNII: 8SKN0B0MIM) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-083-01 1 in 1 BOX 06/28/2021 1 28 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 part346 06/28/2021 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
