hemorrhoidal cooling description, usages, side effects, indications, overdosage, supplying and lots more!

hemorrhoidal cooling

Meijer Distribution Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Meijer Distribution, Inc. Hemorrhoidal Cooling Gel Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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

Hemorrhoidal Cooling Gel

with vitamin E and aloe

COMPARE TO PREPARATION H® COOLING GEL active ingredients

CLEAR, NON-GREASY, NON-STAINING FORMULA

NO UNPLEASANT SCENT

PROMPT COOLING RELIEF FROM PAINFUL BURNING & ITCHING

REDUCES SWOLLEN HEMORRHOIDAL TISSUES

RELIEVES EXTERNAL DISCOMFORT

Package/Label Principal Display Panel
Hemorrhoidal Cooling Gel Carton Image 1 Hemorrhoidal Cooling Gel Carton Image 2

hemorrhoidal cooling

Phenylephrine HCl, Witch hazel GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41250-843
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 0.25 g
WITCH HAZEL 50.0 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
SULISOBENZONE
EDETATE DISODIUM
METHYLPARABEN
polysorbate 80
propylene glycol
PROPYLPARABEN
water
SODIUM CITRATE
ALPHA-TOCOPHEROL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 51 in 1 TUBE
2 NDC:41250-843-24 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2006-05-24


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Be sure to consult your doctor before taking any medication!
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