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Rexall Maximum Strength Hemorrhoidal

Medically reviewed on June 28, 2018

Dosage form: cream
Ingredients: PRAMOXINE HYDROCHLORIDE 10mg in 1g, GLYCERIN 144mg in 1g, PETROLATUM 150mg in 1g, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g
Labeler: Dolgencorp, Inc.
NDC Code: 55910-402

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.

drug facts

Active ingredients                                 Purpose

Glycerin 14.4%.................................................Protectant
Petrolatum 15%...............................................Protectant
Phenylephrine Hydrochloride 0.25%...................Vasoconstrictor
Pramoxine HCl 1%...........................................Local anesthetic




Uses

- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make
bowel movements less painful


Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

Uses

- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to help make
bowel movements less painful
 

Other information


- store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
- for lot number and expiration date, see crimp of tube or see box

Warnings

For external use only.

Ask a doctor before use if you have

- heart disease - high blood pressure - thyroid disease - diabetes
- 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 into rectum by using fingers or any mechanical device or applicator
- use only the provided dispensing cap

Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain,
or other symptoms develop or increase

If pregnant or breast feeding, ask a health professional before use.

Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away


Directions

- adults:when practical, cleanse the affected area by patting or blotting with an
appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft
cloth before applying cream.
- When first opening the tube, puncture foil seal with top end of cap.
- apply externally or in the lower portion of the anal canal only
- apply externally to the affected area up to 4 times daily, especially at night,
in the morning or after each bowel movement
-  for application in the lower anal canal: remove cover from dispensing cap.
Attach dispensing cap to tube. Lubricate dispensing cap well, then gently
insert cap partway into the anus.
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor



Inactive Ingredients aloe barbadensis leaf juice, butylated hydroxyanisole,
cellulose gum, cetyl alcohol, citric acid, disodium EDTA, glyceryl stearate SE,
laureth-23, methylparaben, mineral oil, penthenol, propylene glycol, propyl gallate,
propylparaben, purified water, sodium benzoate, steareth-2, steareth-20,
stearyl alcohol, tocopheryl acetate, xanthan gum





REXALL MAXIMUM STRENGTH HEMORRHOIDAL 
pramoxine hydrochloride, glycerin, phenylephrine hydrochloride and petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-402
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
GLYCERIN (GLYCERIN) GLYCERIN144 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM150 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
CARBOXYMETHYLCELLULOSE SODIUM 
LAURETH-23 
MINERAL OIL 
PANTHENOL 
PROPYL GALLATE 
STEARYL ALCOHOL 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
STEARETH-2 
STEARETH-20 
.ALPHA.-TOCOPHEROL ACETATE, D- 
XANTHAN GUM 
ALOE VERA LEAF 
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:55910-402-031 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
128 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/28/2011
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIOperations
Pharma Pac, LLC140807475manufacture

 
Dolgencorp, Inc.

← See all Rexall Maximum Strength Hemorrhoidal brands

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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