AVEDANA HEMORRHOIDAL COOLING GEL- phenylephrine hcl, witch hazel gel

Avedana HEMORRHOIDAL COOLING Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

Phenylephrine HCl 0.25%

Witch hazel 50.0%

PURPOSES

Vasoconstrictor

Astringent

USES

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporary relief of irritation and burning
• temporarily shrinks hemorrhoidal tissue
• aids in protecting irritated anorectal areas

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 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

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 gel.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• children under 12 years of age: ask a doctor

OTHER INFORMATION

store at 15°C - 30°C (59°F - 89°F)

INACTIVE INGREDIENTS

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E 

QUESTIONS OR COMMENTS?

Call weekdays 8 AM to 5 PM EST at 1-724-733-7381

PRINCIPAL DISPLAY PANEL - TUBE LABEL

Avedana®

HEMORRHOIDAL COOLING GEL

Fast Cooling
Relief

Clear, Non-Greasy Formula with
No Unpleasant ScentPrompt, Cooling Relief from Painful
Burning & ItchingShrinks Swollen Hemorrhoidal TissueRelieves External Discomfort

1 TUBE | 25.5 g | THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.

PRINCIPAL DISPLAY PANEL - CARTON LABEL

Avedana ®

HEMORRHOIDAL COOLING GEL

Fast Cooling
Relief

Clear, Non-Greasy Formula with
No Unpleasant ScentPrompt, Cooling Relief from Painful
Burning & ItchingShrinks Swollen Hemorrhoidal TissueRelieves External Discomfort

1 TUBE INSIDE CARTON | NET WT 0.9 OZ (25.5 g)

INGREDIENTS AND APPEARANCE

AVEDANA HEMORRHOIDAL COOLING GEL 
phenylephrine hcl, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-450
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
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-450-01	1 in 1 CARTON	01/01/2004
1		25.5 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 Drug	M015	01/01/2004

Labeler - Unipack LLC (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack LLC		009248480	manufacture(43749-450)