APJ HEMORRHOIDAL - phenylephrine hydrochloride, mineral oil, petrolatum ointment 
A P J Laboratories Limited

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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PHENYLEPHRINE HYDROCHLORIDE

PETROLATUM

MINERAL OIL


Protectant

Vasoconstrictor

If swallowed, get medical help or contact a Poison Control Center right away.

■ Helps relieve the local itching and discomfort associated with hemorrhoids.

■ Temporarily shrinks hemorrhoidal tissue and relieves burning.

■ Temporarily provides a coating for relief of anorectal discomforts.

■ Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.


For external and/or intrarectal use only



■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 a soft cloth before applying ointment.

■when first opening the tube, puncture foil seal with top end of cap

■apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

■intrarectal use:

    ■remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum

    ■thoroughly cleanse applicator after each use and replace cover

■also apply ointment to external area

■regular use provides continual therapy for relief of symptoms

■children under 12 years of age: ask a doctor




PARAFFIN

BUTYLATED HYDROXYTOLUENE

METHYLPARABEN

PROPYLPARABEN

CHLOROCRESOL

LANOLIN

MAGNESIUM STEARATE

LIGHT MINERAL OIL

DISPLAY PANEL

product
APJ HEMORRHOIDAL 
phenylephrine hydrochloride, mineral oil, petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.55 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM720 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PARAFFIN (UNII: I9O0E3H2ZE) 40 mg  in 1 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 70 mg  in 1 g
METHYLPARABEN (UNII: A2I8C7HI9T) .1 mg  in 1 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) .1 mg  in 1 g
CHLOROCRESOL (UNII: 36W53O7109) .02 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) .5 mg  in 1 g
MAGNESIUM STEARATE (UNII: 70097M6I30) 1 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP) 10 mg  in 1 g
Product Characteristics
Colorwhite (OFF WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-111-1028 g in 1 TUBE
2NDC:46084-111-2057 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/01/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-111)

Revised: 6/2013
Document Id: a0c485a4-d719-42e7-8764-459756dfdae3
Set id: e971a664-c814-4c8a-96ab-7fdaa974335d
Version: 1
Effective Time: 20130601
 
A P J Laboratories Limited