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Family wellness by FRONT PHARMACEUTICAL PLC

Medically reviewed on March 31, 2017

Dosage form: ointment
Ingredients: MINERAL OIL 14g in 100g, PETROLATUM 74.9g in 100g, PHENYLEPHRINE HYDROCHLORIDE .25g in 100g
Labeler: FRONT PHARMACEUTICAL PLC
NDC Code: 69571-006

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.

Active ingredients (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Protectant

Vasoconstrictor

Uses •helps relieve the local itching and discomfort associated with hemorrhoids.

•Temporarily shrinks hemorrhoid tissue and relieves burning.

•Temporarily provides a coating for relief of anorectal burning.

•Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less

painful

Warnings

For external and/or intrarectal 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.

Stop use and ask a doctor if

•bleeding occurs  •condition worsens or does not improve within 7 days.

•introduction of the 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

Adults and children 12 years of age and older for topical use:

•clean the affected area, and pat or dab dry before applying ointment.

•apply to the affected area up to 4 times daily, especially after each bowel movement.

For intrarectal use:

•attach included applicator to tube.

•lubricate applicator tip and gently insert into rectum

•thoroughly clean applicator after each use, and replace cover

Children under 12 years of age: ask a doctor before use.

Other information  store at room temperature 68°  -  77° F (20°-25° C).

Inactive ingredients  beeswax, benzoic acid, cetyl alcohol, glycerin, laureth-23,

methylparaben, propylparaben, stearyl alcohol

Questions? 1-800-639-3803  Weekdays 9 AM to 4 PM EST

FAMILY WELLNESS 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL14 g  in 100 g
PETROLATUM (PETROLATUM) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
BENZOIC ACID 
CETYL ALCOHOL 
GLYCERIN 
LAURETH-23 
METHYLPARABEN 
PROPYLPARABEN 
STEARYL ALCOHOL 
Packaging
#Item CodePackage Description
1NDC:69571-006-021 TUBE in 1 BOX
1NDC:69571-006-0157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/30/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-006)

 
FRONT PHARMACEUTICAL PLC

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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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