PREPARATION H COOLING GEL

Dosage form: gel
Ingredients: phenylephrine hydrochloride 2.5mg in 1g, witch hazel 500mg in 1g
Labeler: Wyeth Consumer Healthcare
NDC Code: 0573-2840

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.

Preparation H Cooling Gel
(phenylephrine HCl and witch hazel)

DRUG FACTS

ACTIVE INGREDIENTS

Phenylephrine HCl 0.25%

Witch hazel 50.0%

PURPOSES

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
  • high blood pressure
  • thyroid disease
  • 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 this product into the rectum by 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 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 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 of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate

QUESTIONS OR COMMENTS?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374.

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H HEMORRHOIDAL Cooling Gel

Fast Cooling Relief

Clear, Non-Greasy Formula with No Unpleasant Scent

Prompt Cooling Relief from Painful Burning and Itching

Shrinks Swollen Hemorrhoidal Tissue

Relieves External Discomfort

NET WT 1.8 OZ (51g)

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

For most recent product information, visit www.preparationh.com

Wyeth Consumer Healthcare

Madison, NJ 07940 USA ©2009 Wyeth

PREPARATION H COOLING GEL 
phenylephrine hcl, witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2840
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride2.5 mg  in 1 g
witch hazel (witch hazel) witch hazel500 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:0573-2840-101 TUBE (TUBE) in 1 CARTON
126 g in 1 TUBE
2NDC:0573-2840-201 TUBE (TUBE) in 1 CARTON
251 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/01/2004
Labeler - Wyeth Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Richmond Division of Wyeth829390827MANUFACTURE, ANALYSIS

Revised: 02/2010
 
Wyeth Consumer Healthcare

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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