Label: AVEDANA HEMORRHOIDAL PAIN RELIEF- mineral oil, petrolatum, phenylephrine hcl ointment
- NDC Code(s): 43749-480-02
- Packager: Unipack 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 18, 2023
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- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSES
-
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
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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.
-
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
- QUESTIONS OR COMMENTS?
-
PRINCIPAL DISPLAY PANEL - 57 g Tube Label
THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.
Avedana ®
HEMORRHOIDAL PAIN RELIEF OINTMENTPrevents Further
Irritation- Prompt, Soothing Relief from Painful
Burning, Itching and Discomfort - Shrinks Swollen Hemorrhoidal Tissue
- Protects Irritated Tissue
- Relieves Internal and External Discomfort
NET WT 2 OZ (57 g)
- Prompt, Soothing Relief from Painful
- PRINCIPAL DISPLAY PANEL - 57 g Carton Label
-
INGREDIENTS AND APPEARANCE
AVEDANA HEMORRHOIDAL PAIN RELIEF
mineral oil, petrolatum, phenylephrine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43749-480 Route of Administration TOPICAL 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 MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 140 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 749 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) CORN OIL (UNII: 8470G57WFM) GLYCERIN (UNII: PDC6A3C0OX) LANOLIN (UNII: 7EV65EAW6H) LANOLIN ALCOHOLS (UNII: 884C3FA9HE) METHYLPARABEN (UNII: A2I8C7HI9T) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) THYME (UNII: CW657OBU4N) WHITE WAX (UNII: 7G1J5DA97F) TOCOPHEROL (UNII: R0ZB2556P8) Product Characteristics Color yellow (smooth yellow ointment) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43749-480-02 1 in 1 CARTON 01/06/2021 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 part346 03/01/2004 Labeler - Unipack LLC (009248480) Establishment Name Address ID/FEI Business Operations Unipack LLC 009248480 manufacture(43749-480)
