Your browser does not support JavaScript! HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [WESTERN FAMILY FOODS INC]
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RxNorm Names

HEMORRHOIDAL COOLING (phenylephrine hcl, witch hazel) gel
[Western Family Foods Inc]


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 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

Package/Label Principal Display Panel

HEMMORRDODIAL Cooling Gel

Fast Cooling Relief

Clear, Non-Greasy Formula with No Unpleasant Scent

Prompt Cooling Relief from Painful Burning And Itching

Shrinks Swollen Hemorrhoidal Tissues

Relieves External Discomfort

WITH VITMAIN E AND ALOE

COMPARE TO THE ACTIVE INGREDIENTS OF PREPARATION H® COOLING GEL

Hemorrhoidal Cooling Gel Carton Image
HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55312-843
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 
EDETATE DISODIUM 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
.ALPHA.-TOCOPHEROL 
SULISOBENZONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-843-241 in 1 CARTON
151 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/24/2012
Labeler - Western Family Foods Inc (192166072)

Revised: 10/2012
 
Western Family Foods Inc

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