PREPARATION H COOLING GEL description, usages, side effects, indications, overdosage, supplying and lots more!

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PREPARATION H COOLING GEL

Wyeth Consumer Healthcare

Preparation H Cooling Gel (phenylephrine HCl and witch hazel)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

PREPARATION H COOLING GEL

phenylephrine HCl, witch hazel GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0573-2840
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
WITCH HAZEL 500 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 26 in 1 TUBE
2 51 in 1 TUBE
3 NDC:0573-2840-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2004-01-01


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