CVS HEMORRHOIDAL- glycerin phenylephrine hci pramoxine hci white petrolatum cream

CVS Hemorrhoidal by

Drug Labeling and Warnings

CVS Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                  Purpose

Glycerin 14.4%...................................... Protectant

Phenylephrine HCI 0.25%........................ Vasoconstrictor

Pramoxine HCI 1%..................................Local anesthetic

White Petrolatum 15%.............................Protectant

PURPOSE

Uses

• For temporary relief of pain, soreness and burning
• Helps relieve the local itching and discomfort associated with hemorrhoids
• Temporarily shrinks hemorrhoidal tissue
• Temporarily provides a coating for relief of anorectal discomforts
• Temporarily protects the inflamed, irritaed anorectal surface to help make bowel movements less painful

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have

• heart disease
• high blood pressure
• Thyroid disease
• Diabetes
• Difficulty in urination due to enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

WHEN USING

When using this product

• Do not exceed the recommended daily dosage unless directed by a doctor
• Do not put into rectum by using fingers or any mechanical device or applicator

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions

• Adults: when practical, cleanse the affected area by patting or blottign with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying.
• When first opening the tube, puncture foil seal with top end of cap
• Apply externally or in the lower portion of the anal canal only
• Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube, lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
• Thoroughly cleanse dispensing cap after each use and replace cover.
• Children under 12 years of age: ask a doctor

PURPOSE

Other Information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe barbadensis leaf extract, butylated hydroxytoluene, cetosteraly alcohol, cetyl esters, cetyl palmitate, distilled water, glycerol monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate hydrate, stearic acid, tocopherol acetate

DOSAGE & ADMINISTRATION

DISTRIBUTED BY:

CVS PHARMACY, INC.

ONE CVS DRIVE

WOONSOCKET, RI 02895 USA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEMORRHOIDAL 
glycerin phenylephrine hci pramoxine hci white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-752
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-752-28	1 in 1 BOX	09/12/2016
1		1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/17/2014

Labeler - CVS Pharmacy, Inc. (062312574)