CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL- phenylephrine hydrochloride and witch hazel gel

CVS HEALTH HEMORRHOIDAL COOLING by

Drug Labeling and Warnings

CVS HEALTH HEMORRHOIDAL COOLING by is a Otc medication manufactured, distributed, or labeled by CVS, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purposes
Phenylephrine HCl 0.25%	Vasoconstrictor
Witch hazel 50%	Astringent

Uses

• temporary relief of irritation and burning
• temporarily shrinks hemorrhoidal tissue
• helps relieve the local itching and discomfort associated with hemorrhoids
• aids in protecting irritated anorectal areas

Warnings

For external use only

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 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 unless directed by a doctor
• 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 worsens or does not improve within 7 days. These may be signs of a serious condition.

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: 800-222-1222.

Directions

• adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or soft cloth before applying gel.
• 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: ask a doctor

Other Information

• store at 15 to 30° C (59 to 86°F)
• close cap tightly after use
• do not use if seal on tube is punctured or missing

Inactive Ingredients

Aloe barbadensis (aloe) leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions or comments?

866-323-0107 or www.natureplex.com

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

CVSHealth™

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

NDC: 69842-843-01

Hemorrhoidal Cooling Gel
WITH SOOTHING ALOE / FAST COOLING RELIEF

• Clear, non-greasy formula with a pleasant scent
• Shrinks swollen hemorrhoidal tissue
• Prompt cooling relief from painful burning & itching
• Relieves external discomfort

NET WT 0.9 OZ (26 g)

INGREDIENTS AND APPEARANCE

CVS HEALTH HEMORRHOIDAL COOLING   HEMORRHOIDAL
phenylephrine hydrochloride and witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-843
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-843-01	1 in 1 CARTON	11/15/2006
1		26 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	01/01/2004

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(69842-843)