HEMORRHOIDAL COOLING GEL - phenylephrine and witch hazel gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)
Available from:
Amerisource Bergen
INN (International Name):
PHENYLEPHRINE HYDROCHLORIDE
Composition:
PHENYLEPHRINE HYDROCHLORIDE 0.25 g in 1 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Vasoconstrictor Astringent - Helps relieve the local itching and discomfort associated with hemorrhoids - Temporary relief of itching and burning - Temporarily shrinks hemorrhoidal tissue - Aids in protecting irritated anorectal areas
Authorization status:
OTC monograph final
Authorization number:
24385-421-06

HEMORRHOIDAL COOLING GEL - phenylephrine and witch hazel gel

Amerisource Bergen

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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DRUG FACTS

ACTIVE INGREDIENT

Phenylephrine HCI, 0.25%

Witch Hazel, 50%

PURPOSE

Vasoconstrictor

Astringent

USES

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporary relief of itching 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

thyroid disease

high blood pressure

diabetes

difficulty in urination due to enlargement of the prostate

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 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 breastfeeding,

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: ask a doctor.

OTHER INFORMATION

Store at room temperature: 20° - 25° C (68° - 77° F)

INACTIVE INGREDIENTS

aloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben,

polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water

PACKAGE INFORMATION

GOOD NEIGHBOR PHARMACY

NDC 24385-421-06

HEMORRHOIDAL

Cooling Gel

with Vitamin E and Aloe

Fast cooling relief from painful burning and itching

Net Wt. 0.9 oz. (26 g)

Fast cooling relief

Clear, non-greasy formula with no unpleasant scent

Prompt cooling relief from painful burning and itching

Shrinks swollen hemorrhoidal tissue

Relieves external discomfort

*Compare to active ingredients in Preparation H® Cooling Gel

FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN

OR MISSING.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the

registered trademark Preparation H®.

Distributed By

AmerisourceBergen

Valley Forge, PA 19482-0959

Visit us at www.myGNP.com

HEMORRHOIDAL COOLING GEL

phenylephrine and witch hazel gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2438 5-421

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

0 .25 g

in 1 g

WITCH HAZEL (UNII: 10 1I4J0 U34) (WITCH HAZEL - UNII:10 1I4J0 U34)

WITCH HAZEL

50 g in 1 g

Inactive Ingredients

Amerisource Bergen

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

SULISO BENZO NE (UNII: 1W6 L6 29 B4K)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

HYDRO XYETHYL CELLULO SE ( 2 0 0 0 CPS AT 1%) (UNII: S38 J6 RZN16 )

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2438 5-421-0 6

1 in 1 BOX

1

26 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt346

0 8 /0 1/20 0 6

Labeler -

Amerisource Bergen (007914906)

Revised: 1/2010

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