REXALL MAXIMUM STRENGTH HEMORRHOIDAL - pramoxine hydrochloride, glycerin, phenylephrine hydrochloride and petrolatum cream 
Dolgencorp, 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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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



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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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
LAURETH-23 (UNII: N72LMW566G)  
MINERAL OIL (UNII: T5L8T28FGP)  
PANTHENOL (UNII: WV9CM0O67Z)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-20 (UNII: L0Q8IK9E08)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-402-031 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/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 6/2011
Document Id: 600fd5a6-bacf-4d4d-b6da-8a1bdca490c0
Set id: d56768b7-dc2b-4527-a4ba-d3d462c32be3
Version: 1
Effective Time: 20110628
 
Dolgencorp, Inc.