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

Rexall Maximum Strength Hemorrhoidal by

Drug Labeling and Warnings

Rexall Maximum Strength Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc., Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                 Purpose

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

PURPOSE

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

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

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-402-03	1 in 1 CARTON
1		28 g in 1 TUBE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/28/2011

Labeler - Dolgencorp, Inc. (068331990)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture