AVEDANA HEMORRHOIDAL MAXIMUM STRENGTH- hemorrhoidal cream

Avedana Hemorrhoidal by

Drug Labeling and Warnings

Avedana Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Glycerin 14.4%

Phenylephrine HCL  0.25%

Pramoxine HCl  1%

White petrolatum  15%

Purpose

Protectant

Vasoconstrictor

Local anasthetic

Protectant

Uses

-for temporary relief of pain, soreness, and burning.

-helps relieve the local itching and discomfort associated with hemorrhoids.

-temporarily shrinks hemorrhoidal tissue.

-temporarily provides a coating for relief of anorectal discomforts.

-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Warnings

For external 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

-do not put 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

-an allergic reaction develops

-the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase

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

-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 cream.  When first opening the tube, puncture foil seal with top end of cap.  Apply externally or in the lower portion of the anal canal only.  Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

-For application in the lower anal canal: remove cover from dispensing cap.  Attach dispensing cap to tube.  Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

-thoroughly cleanse dispensing cap after each use and replace cover.

-children under 12 years of age: ask a doctor.

Directions

Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

Other information

store at 15ºC - 30ºC (59ºF -86ºF)

Inactive ingredients

Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E Tube Label

Tube Label 0.9oz

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 0.9 OZ (26 g)

0.9oz Carton Label

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g)

1.8oz Tube Label

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g)

1.8oz Carton Label

INGREDIENTS AND APPEARANCE

AVEDANA HEMORRHOIDAL   MAXIMUM STRENGTH
hemorrhoidal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-470
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MINERAL OIL (UNII: T5L8T28FGP)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
ALOE (UNII: V5VD430YW9)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARIC ACID (UNII: 4ELV7Z65AP)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-470-01	1 in 1 CARTON	11/04/2020
1	NDC: 43749-470-03	25.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 43749-470-02	1 in 1 CARTON	11/04/2020
2	NDC: 43749-470-04	51 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	11/04/2020

Labeler - Unipack LLC (009248480)

Registrant - Unipack LLC (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack LLC		009248480	manufacture(43749-470)