HEMORRHOIDAL - mineral oil,petrolatum,phenylephrine ointment 
Kareway Product, 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

Uses

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.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into the rectum causes additional pain

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

Other information

Other information

Store at 20o to 25oC (68o to 77oF)

Inactive ingredients

benzoic acid, butylated hydroxanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thyme oil, tocopherols excipient, white wax

Active ingredients

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

Purpose

Protectant

Protectant

Vasoconstrictor


Package label

Pure-Aid Hemorrhoidal Ointment
image of carton label
HEMORRHOIDAL 
mineral oil,petrolatum,phenylephrine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM71.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CORN OIL (UNII: 8470G57WFM)  
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SHARK LIVER OIL (UNII: 4B24275HEU)  
THYME OIL (UNII: 2UK410MY6B)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0056-21 in 1 CARTON
157 g in 1 TUBE
2NDC:67510-0056-11 in 1 CARTON
228 g in 1 TUBE
3NDC:67510-0056-61 in 1 CARTON
319 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/02/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 7/2012
Document Id: 34a8ecee-2848-4827-9b4e-910a7aaed43d
Set id: 6d41efab-dede-4846-a23b-53b0eab252b5
Version: 1
Effective Time: 20120702
 
Kareway Product, Inc.