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hemorrhoidal relief

Rite Aid Corporation

Rite Aid Corporation Hemorrhoidal Relief Cooling Gel Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purpose

Vasoconstrictor

Astringent

hemorrhoidal relief 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

hemorrhoidal relief 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 of Preparation H® Cooling Gel

hemorrhoidal relief 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

phenylephrine HCI 0.25%

witch hazel 50.0%

with vitamin E and aloe

NET WT 1.8 OZ (51 g)

hemorrhoidal relief

Phenylephrine HCl, Witch hazel GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-0843
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:11822-0843-1 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2014-05-11


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