HEMORRHOIDAL COOLING- phenylephrine hydrochloride and witch hazel gel 
Walgreen Company

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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Active ingredient

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purpose

Vasoconstrictor

Astringent

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily relieves 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
  • diabetes
  • thyroid disease
  • trouble urinating due to an enlarged 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
  • 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 gets worse 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 and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or 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 20°-25°C (68°-77°F)

Inactive ingredients

aloe vera gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Preparation H® Cooling Gel active ingredients

HEMORRHOIDAL COOLING GEL

CLEAR, NON-GREASY FORMULA WITH NO UNPLEASANT SCENT

SHRINKS SWOLLEN HEMORRHOIDAL TISSUES

PROMPT COOLING RELIEF FROM PAINFUL BURNING AND ITCHING

RELIEVES EXTERNAL DISCOMFORT

FAST COOLING RELIEF

Hemorrhoidal Cooling Gel Carton Image 1

Hemorrhoidal Cooling Gel Carton Image 1

Hemorrhoidal Cooling Gel Carton Image 2

Hemorrhoidal Cooling Gel Carton Image 2

HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0843
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL50.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
SULISOBENZONE 
EDETATE DISODIUM 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
ALPHA-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:0363-0843-011 in 1 CARTON
125 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/19/2011
Labeler - Walgreen Company (008965063)

Revised: 11/2011
Document Id: 9fb5fb1e-a852-4ea8-8bc0-307054039b6b
Set id: 9fb5fb1e-a852-4ea8-8bc0-307054039b6b
Version: 1
Effective Time: 20111122
 
Walgreen Company