REXALL HEMORRHOIDAL- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream

Rexall Hemorrhoidal by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Glycerin 14.4%	Anorectal (Hemorrhoidal) Cream
Petrolatum 15%	Anorectal (Hemorrhoidal) Cream
Phenylephrine HCl 0.25%	Anorectal (Hemorrhoidal) Cream
Pramoxine HCl 1%	Anorectal (Hemorrhoidal) Cream

Uses

• Temporarily relieves itching and discomfort associated with hemorrhoids.
• Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders.
• Temporarily shrinks hemorrhoidal tissue
• Temporarily forms a protective coating over inflamed tissues to help prevent dryness.
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Not for prolonged use.

Do not use in the eyes or nose.

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 apply to large areas of the body
• do not exceed the recommended daily dosage unless directed by a doctor
• do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Stop use and ask a physician if

• bleeding occurs
• the condition worsens or does not improve within 7 days
• an allergic reaction develops
• the symptom being treated does not subside or redness, irritation, swelling or pain develops, persists, or increases.

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 the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream
• apply externally to the affected area up to 4 times daily or after each bowel movement
• FOR INTRARECTAL USE: Remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, and then gently insert the dispensing cap into the rectum.
• thoroughly cleanse dispensing cap after each use, and replace the cover
• children under 12 years old: consult a physician

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, BHA, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethylcellulose, steareth-2, steareth-20, stearyl alcohol, tocopherol (vitamin E) acetate, xanthan gum

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC: 55910-331-24

Since 1903
Rexall®

MAXIMUM STRENGTH

Hemorrhoidal Cream

• Rapid, soothing pain relief from burning, itching and discomfort
• Protects irritated tissue

NET WT 1 OZ (28 g)

INGREDIENTS AND APPEARANCE

REXALL HEMORRHOIDAL 
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX)	Glycerin	0.144 mg  in 1 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	0.0025 mg  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056)	Pramoxine Hydrochloride	0.1 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U)	Petrolatum	0.15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butylated Hydroxyanisole (UNII: REK4960K2U)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Laureth-23 (UNII: N72LMW566G)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Panthenol (UNII: WV9CM0O67Z)
Propyl Gallate (UNII: 8D4SNN7V92)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Sodium Benzoate (UNII: OJ245FE5EU)
Steareth-2 (UNII: V56DFE46J5)
Steareth-20 (UNII: L0Q8IK9E08)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol (UNII: H4N855PNZ1)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-331-24	1 in 1 CARTON	03/01/2014
1		28 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	03/01/2014

Labeler - Dolegencorp,LLC (068331990)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(55910-331)