Your browser does not support JavaScript! PREFERRED PLUS HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL) CREAM [KINRAY INC.]
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PREFERRED PLUS HEMORRHOIDAL (phenylephrine hydrochloride, witch hazel) cream
[Kinray 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

Drug Facts

Active ingredients

Phenylephrine hydrochloride 0.25%

Witch hazel 50.0%

Vasoconstrictor

Astringent

Uses

  • temporarily relieves irritation and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • 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 occur
  • 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)
  • for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

  • aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal Display Panel - 1 oz Carton Label

TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.

NDC 61715-093-01

Preferred Plus Pharmacy®

HEMORRHOIDAL

Cooling Gel with aloe

*Compare to the active ingredients in PREPARATION H® Cooling Gel

Fast Cooling Relief

  • Clean, Non-Greasy Formula with No Unpleasant Scent
  • Prompt Cooling Relief from Painful Burning and Itching
  • Shrinks Swollen Hemorrhoidal Tissue
  • Relieves External Discomfort

SATISFACTION GUARANTEED

Preferred Plus Pharmacy®

NET WT 1 OZ (28 g)

Principal Display Panel - 1 oz Carton Label
PREFERRED PLUS HEMORRHOIDAL 
phenylephrine hydrochloride, witch hazel cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61715-093
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride2.5 mg  in 1 L
witch hazel (witch hazel) witch hazel500 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
edetate disodium 
hydroxyethyl cellulose (100 mpa.s at 2%) 
methylparaben 
polysorbate 80 
propylene glycol 
propylparaben 
water 
sodium citrate 
.alpha.-tocopherol acetate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-093-011 in 1 CARTON
10.028 L in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/28/2014
Labeler - Kinray Inc. (012574513)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Products157469086MANUFACTURE(61715-093)

Revised: 3/2014
 
Kinray Inc.

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