Your browser does not support JavaScript! HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE AND WITCH HAZEL) GEL [WALGREEN COMPANY]
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HEMORRHOIDAL COOLING GEL (phenylephrine and witch hazel) gel
[Walgreen Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

Phenylephrine HCI, 0.25%
Witch Hazel, 50.0%

PURPOSE

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
  • thyroid disease
  • high blood pressure
  • 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 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 - TUBE

Walgreens


FOR YOUR SAFETY, TUBE IS SEALED. DO NOT USE IF TUBE SEAL UNDER CAP IS BROKEN OR MISSING. This package has an outer carton. Do not buy if outer carton is missing.

HEMORRHOIDAL
Cooling Gel

Fast Cooling Relief with Aloe

  • Clear, non-greasy formula with no unpleasant odor
  • Relief from painful burning and itching
  • Shrinks swollen hemorrhoidal tissue 
  • With vitamin E


NET WT 0.9 OZ (26 g)


Distributed by Walgreens Co. Deerfield, IL 60015-4616
Made in U.S.A.

100% Satisfaction Guaranteed
www.walgreens.com

tube

PACKAGE INFORMATION - CARTON

Walgreens

NDC 0363-0400-16

Retain Carton for Complete Information

HEMORRHOIDAL
Cooling Gel


Fast Cooling Relief with Aloe

  • Clear, non-greasy formula with no unpleasant odor
  • Relief from painful burning and itching
  • Shrinks swollen hemorrhoidal tissue 
  • With vitamin E

NET WT 0.9 OZ (26 g)

Compare to Preparation H® Cooling Gel active ingredients*

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

Distributed by Walgreens Company
Deerfield, IL 60015-4616    Made in U.S.A.

100% Satisfaction Guaranteed    www.walgreens.com

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, Inc., owner of the registered trademark Preparation H®.


carton

HEMORRHOIDAL COOLING GEL 
phenylephrine and witch hazel gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-0400
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 1 g
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL50 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
SULISOBENZONE 
EDETATE DISODIUM 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SODIUM CITRATE 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0400-161 in 1 BOX
126 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2006
Labeler - Walgreen Company (008965063)

Revised: 2/2010
 
Walgreen Company

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