Label: HEMORRHOIDAL-OINTMENT- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 82433-101-01 - Packager: Rrhoid Rage
- 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 June 6, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
-Helps relieve the pain, itching, and burning associated with hemorrhoids.
-Temporarily reduces the swelling associated with irritated hemorrhoidal
tissue and other anorectal disorders.
-Temporarily provides a coating for relief of anorectal discomforts.
-Temporarily protects irritated areas and inflamed perianal skin. -
WARNINGS
For external and/or intrarectal use only.
Ask a 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 a doctor or pharmacist before use if you are presently taking a prescription drug for high
blood pressure or depression.When using this product
-Avoid contact with eyes.
-Do not exceed recommended daily dosage unless directed by a doctor.
-Do not put this product into the rectum by using fingers or any mechanical device or applicator.Stop use and ask a doctor if
-Bleeding occurs.
-Condition worsens or does not improve within 7 days.
-Allergic reaction occurs to ingredients in this product.
-Symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase.If pregnant or breastfeeding, ask a doctor before use.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
-When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
-Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.
-Children under 12 years of age: consult a doctor.Other information
-Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEMORRHOIDAL-OINTMENT
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82433-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g Inactive Ingredients Ingredient Name Strength BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) ALOE (UNII: V5VD430YW9) SYNTHETIC BEESWAX (UNII: 08MNR5YE2R) GLYCERIN (UNII: PDC6A3C0OX) WITCH HAZEL (UNII: 101I4J0U34) METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82433-101-01 1 in 1 CARTON 06/06/2022 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 06/06/2022 Labeler - Rrhoid Rage (035330878) Registrant - Rrhoid Rage (035330878)
