REXALL HEMORRHOIDAL COOLING GEL- witch hazel and phenylephrine hydrochloride cream

Rexall Hemorrhoidal Cooling Gel by

Drug Labeling and Warnings

Rexall Hemorrhoidal Cooling Gel by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Hamamelis virginiana (witch hazel) 50%	Astringent
Phenylephrine hydrochloride 0.25%	Vasoconstrictor

Uses

• temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
• temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
• temporarily shrinks hemorrhoidal tissue
• aids in protecting irritated anorectal areas
• temporary relief of burning

Warnings

For external use only.

Do not use this product

• if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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

Stop use and ask a doctor if

• condition worsens or does not improve within 7 days
• bleeding occurs

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: 800-222-1222.

Directions

• Adults
  • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
  • apply externally to affected area up to 4 times daily or after each bowel movement
• Children under 12 years old: Ask a doctor.

Other information

• Store at 15 to 30°C (59 to 86°F)
• Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

NDC: 55910-332-24

Since 1903
Rexall®

CLEAR, NON-GREASY FORMULA

Hemorrhoidal Cooling Gel

Enriched
with
Aloe

• Prompt cooling relief from painful burning & itching
• Relieves external discomfort

NET WT 0.9 OZ (26 g)

INGREDIENTS AND APPEARANCE

REXALL HEMORRHOIDAL COOLING GEL 
witch hazel and phenylephrine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	0.5 mg  in 1 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	0.0025 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Benzophenone (UNII: 701M4TTV9O)
Edetate Disodium (UNII: 7FLD91C86K)
Hydroxyethyl Cellulose (280 Mpa.S At 2%) (UNII: 12VCE9HR9E)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Anhydrous Trisodium Citrate (UNII: RS7A450LGA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-332-24	1 in 1 CARTON	03/18/2014
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	03/18/2014

Labeler - DOLGENCORP, LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(55910-332)