MEDICATED HEMORRHOIDAL CVS- phenylephrine hcl .25% witch hazel extract 50% spray 
CVS

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.

----------

Drug Facts

Active ingredients

Phenylephrine HCl 0.25%

Witch Hazel Extract 50.0%

Purpose

Vasoconstrictor

Astringent

Uses

Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders. Ais in protecting irritated anorectal areas.

Warnings

For external use only.

When using this product

avoids spraying in eyes. Contents under pressure. Do not puncture or incinerate. DO not store at temperatures above 120F.

  • 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.

Ask a doctor of pharmacist 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.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Spray rectal area until thoroughly moist. Wipe off excess with tissue. Gently dry by patting or blotting with a tissue or a soft cloth. Apply 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: Consult a doctor.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzophenone-4, Disodium EDTA, Hydroxyethylcellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium Citrate, Tocopheryl Acetate, Water.

label frontlavel back

MEDICATED HEMORRHOIDAL  CVS
phenylephrine hcl .25% witch hazel extract 50% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE.25 g  in 100 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-290-0385 g in 1 CAN; Type 0: Not a Combination Product11/13/201401/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/13/201401/08/2018
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-290)

Revised: 1/2018
 
CVS