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Rexall Maximum Strength Hemorrhoidal

Medically reviewed on July 1, 2016

Dosage form: cream
Ingredients: GLYCERIN 14.4g in 100g, PETROLATUM 15g in 100g, PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g, PRAMOXINE HYDROCHLORIDE 1g in 100g
Labeler: Dolgencorp, Inc.
NDC Code: 55910-406

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.

Rexall Maximum Strength Hemorrhoidal

Active ingredients  
Glycerin 14.4%
Petrolatum 15%
Phenylephrine Hydrochloride 0.25%
Pramoxine HCl 1%

Purpose

Protectant
Protectant
Vasoconstrictor
Local anesthetic

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporary relieves burning
  • aid 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 unless directed by a doctor
  • do not put this product into 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.
  • 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)
  • for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

aloe barbadensis leaf, cetearyl alcohol, cetyl alcohol, glycerol monostearate,  mineral oil, peg 40 castor oil, propylene glycol, purified water, 
stearyl alcohol, tocopheryl acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

REXALL MAXIMUM STRENGTH HEMORRHOIDAL

NET WT 1 OZ (28 g)

REXALL MAXIMUM STRENGTH HEMORRHOIDAL 
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-406
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN14.4 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM15 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
PEG-40 CASTOR OIL 
PROPYLENE GLYCOL 
WATER 
STEARYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:55910-406-0328 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/29/2016
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-406)

 
Dolgencorp, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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