FAMILY WELLNESS- mineral oil, petrolatum, phenylephrine hcl ointment 
FRONT PHARMACEUTICAL PLC

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Active ingredients (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purposes

Protectant

Protectant

Vasoconstrictor

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

•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.

, ask a health professional before use. If pregnant or breast-feeding

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

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.

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

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

methylparaben, propylparaben, stearyl alcohol

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

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FAMILY WELLNESS 
mineral oil, petrolatum, phenylephrine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-006
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) PETROLATUM74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURETH-23 (UNII: N72LMW566G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-006-021 in 1 BOX03/30/2017
1NDC:69571-006-0157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/30/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-006)

Revised: 10/2023
Document Id: 08ad6b35-733b-c9d3-e063-6294a90acfed
Set id: cfdd61e3-e12e-491c-b2a8-90fae19e8870
Version: 3
Effective Time: 20231027
 
FRONT PHARMACEUTICAL PLC