AVEDANA HEMORRHOIDAL PAIN RELIEF- mineral oil, petrolatum, phenylephrine hcl ointment 
Unipack LLC

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.

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Avedana ® Hemorrhoidal Pain Relief Ointment

(Mineral Oil, Petrolatum and Phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

PURPOSES

Protectant

Protectant

Vasoconstrictor

USES

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

do not exceed the recommended daily dosage unless directed by a doctor.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

store at 15°C - 30°C (59°F -86°F)

INACTIVE INGREDIENTS

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax

QUESTIONS OR COMMENTS?

Call weekdays 9 AM to 5 PM EST at 1-724-733-7381

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 OINTMENT

Prevents Further
Irritation

NET WT 2 OZ (57 g)

Principal Display Panel - 57 g Tube Label

PRINCIPAL DISPLAY PANEL - 57 g Carton Label

Avedana ®

HEMORRHOIDAL PAIN RELIEF OINTMENT

Prevents Further Irritation
•Prompt, Soothing Relief from Painful
Burning, Itching, & Discomfort
•Shrinks Swollen Hemorrhoidal Tissue
•Protects Irritated Tissue
•Relieves Internal & External Discomfort

1 TUBE | NET WT 2 OZ (57 g)

Principle Display Panel - 57 g Carton Label

AVEDANA HEMORRHOIDAL PAIN RELIEF 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-480
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (smooth yellow ointment) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-480-021 in 1 CARTON01/06/2021
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/01/2004
Labeler - Unipack LLC (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-480)

Revised: 1/2023
Document Id: f28f24d3-cf95-e27d-e053-2a95a90aae7b
Set id: b6793080-c727-4553-ae33-d387eb861ca3
Version: 3
Effective Time: 20230118
 
Unipack LLC