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Hemorrhoidal Cooling Gel by McKesson

Medically reviewed on Feb 5, 2018

Dosage form: gel
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 0.25g in 1g, WITCH HAZEL 50g in 1g
Labeler: McKesson
NDC Code: 49348-811

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.

DRUG FACTS

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

INACTIVE INGREDIENTSaloe barbadensis gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, vitamin E, water


PACKAGE INFORMATION - TUBE

Sunmark®

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-811-32

Hemorrhoidal Cooling Gel

Fast Cooling Relief

WITH VITAMIN E AND ALOE

NET WT. 1.8 OZ (51 g)


This tube is sealed and packaged in a carton. Do not buy if carton is missing. Do not use if the seal under the cap has been punctured or if the tube is damaged.

Distributed by McKesson
One Post Street
San Francisco, CA 94104
Money Back Guarantee

PACKAGE INFORMATION - CARTON

Sunmark®

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-811-32

Hemorrhoidal Cooling Gel


Fast Cooling Relief

Clear, non-greasy formula with no unpleasant scent
Prompt cooling relief from painful burning and itching

WITH VITAMIN E AND ALOE

NET WT. 1.8 OZ (51 g)



Another Quality Product Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee
Please visit us at www.sunmarkbrand.com

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

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



HEMORRHOIDAL COOLING GEL 
phenylephrine and witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-811
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 Description
1NDC:49348-811-321 TUBE (TUBE) in 1 BOX
151 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/15/2006
Labeler - McKesson (177667227)

 
McKesson

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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