SuperValu Inc. Hemorrhoidal Cooling Gel Drug Facts

Equaline hemorrhoidal cooling by

Drug Labeling and Warnings

Equaline hemorrhoidal cooling by is a Otc medication manufactured, distributed, or labeled by Supervalu Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EQUALINE HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel gel 
Supervalu Inc

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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SuperValu Inc. Hemorrhoidal Cooling Gel Drug Facts

Active ingredients

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purpose

Vasoconstrictor

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

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?

1-877-932-7948

Package/Label Principal Display Panel

compare to Preparation H® Cooling Gel active ingredients

hemorrhoidal cooling gel

prompt cooling relief from painful burning and itching

clear, non-greasy formula with no unpleasant scent

shrinks swollen hemorrhoidal tissue – relieves external discomfort

fast cooling relief

NET WT 0.9 OZ (25g)

EQUALINE HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-843
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: 41163-843-01	1 in 1 CARTON	01/15/2009	12/07/2017
1		25 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	01/15/2009	12/07/2017

Labeler - Supervalu Inc (006961411)

Revised: 11/2019

Document Id: 2b52d1ce-2690-4c66-8dd7-209c40b68d82

34390-5

Set id: 57be9191-c381-4178-83ef-b0d04e9418d8

Version: 3

Effective Time: 20191114

 

Supervalu Inc