CVS Pharmacy, Inc. Hemorrhoidal Cooling Gel Drug Facts

cooling by

Drug Labeling and Warnings

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

Drug Details [pdf]

COOLING HEMORRHOIDAL- phenylephrine hcl, witch hazel gel 
CVS Pharmacy

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.

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CVS Pharmacy, Inc. Hemorrhoidal Cooling Gel Drug Facts

Active ingredients

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purpose

Vasoconstrictor

Astringent

Uses

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily relieves irritation and burning
• 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 occurs
• 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)

Inactive ingredients

aloe vera gel, benzophenone-4, edetate disodium, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the active ingredients in Preparation H® Cooling Gel

Hemorrhoidal Cooling Gel

WITH VITAMIN E & ALOE / FAST COOLING RELIEF

Clear, non-greasy formula with no unpleasant scent

Shrinks swollen hemorrhoidal tissue

Prompt cooling relief from painful burning & itching

Relieves external discomfort

NET WT 0.9 OZ (25 g)

COOLING  HEMORRHOIDAL
phenylephrine hcl, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SULISOBENZONE (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-843-01	1 in 1 CARTON	06/09/2005	08/31/2018
1		25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 59779-843-24	1 in 1 CARTON	06/09/2005	10/04/2014
2		51 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	06/09/2005	08/31/2018

Labeler - CVS Pharmacy (062312574)

Revised: 11/2019

Document Id: beccf543-3fd6-4725-9a70-7ff47b5a5125

34390-5

Set id: 5628d583-d655-48eb-a403-6a31672deb2e

Version: 5

Effective Time: 20191125

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