FAMILY WELLNESS- mineral oil, petrolatum, phenylephrine hcl ointment

Family wellness by

Drug Labeling and Warnings

Family wellness by is a Otc medication manufactured, distributed, or labeled by FRONT PHARMACEUTICAL PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram)

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

PURPOSE

Purposes

Protectant

Protectant

Vasoconstrictor

INDICATIONS & USAGE

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

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

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

away.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

methylparaben, propylparaben, stearyl alcohol

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	14 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	74.9 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-006-02	1 in 1 BOX	03/30/2017
1	NDC: 69571-006-01	57 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/30/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-006)