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

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

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

*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


carton

HEMORRHOIDAL COOLING GEL 
phenylephrine and witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24385-421-061 in 1 BOX
126 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/01/2006
Labeler - Amerisource Bergen (007914906)

Revised: 1/2010
Document Id: ba83b1fe-23a3-4673-8b31-e47d02cf1cd7
Set id: ca59ecb1-2a80-41f3-a0c8-816e1590c611
Version: 1
Effective Time: 20100104
 
Amerisource Bergen