CVS HEMORRHOIDAL COOLING

Dosage form: gel
Ingredients: WITCH HAZEL 500mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g
Labeler: CVS Pharmacy
NDC Code: 59779-265

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                                        Purpose

Phenylephrine hydrochloride 0.25%.............................Vasoconstrictor
Witch hazel 50.0%.....................................................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


Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.


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
 

Other information
- store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

Warnings

For external use only.

Ask a doctor before use if you have

- heart disease - high blood pressure - thyroid disease - diabetes
- trouble urinating due to an enlarged prostate gland

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 into 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 the 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


Inactive Ingredients aloe barbadensis leaf juice, benzophenone-4, disodium EDTA,
hydroxyethylcellulose. methyl paraben, polysorbate 80, propylene glycol, propylparaben,
purified water, sodium citrate, tocopheryl acetate



CVS HEMORRHOIDAL COOLING  
witch hazel, phenylephrine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-265
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL500 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SULISOBENZONE 
PROPYLENE GLYCOL 
POLYSORBATE 80 
ALPHA-TOCOPHEROL 
ALOE VERA LEAF 
ANHYDROUS TRISODIUM CITRATE 
EDETATE DISODIUM 
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:59779-265-611 TUBE (TUBE) in 1 CARTON
151 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34611/18/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

Revised: 11/2010
 
CVS Pharmacy

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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