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cooling hemorrhoidal

Dosage form: gel
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g, WITCH HAZEL 50.0g in 100g
Labeler: CVS Pharmacy
NDC Code: 59779-843

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.

CVS Pharmacy, Inc. Hemorrhoidal Cooling Gel Drug Facts

Active ingredients

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 the active ingredients in Preparation H® Cooling Gel

HEMORRHOIDAL COOLING GEL

WITH VITAMIN E & ALOE

FAST COOLING RELIEF

Clear, non-greasy formula with no unpleasant scent

Shrinks swollen hemorrhoidal tissue

Prompt cooling relief from painful burning & itching

Relieves external discomfort

NET WT .9 OZ (25 g)

COOLING  HEMORRHOIDAL
phenylephrine hcl, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-843
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:59779-843-011 TUBE in 1 CARTON
125 g in 1 TUBE
2NDC:59779-843-241 TUBE in 1 CARTON
251 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/09/2005
Labeler - CVS Pharmacy (062312574)

Revised: 07/2014
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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