FAMILY WELLNESS- glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream

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)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL 1%

White petrolatum 15%

PURPOSE

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

INDICATIONS & USAGE

Uses

• for temporary relief of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily provides a coating for relief of anorectal discomforts
• temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

WARNINGS

Warnings

For external use only.

When using this product

• do not put this product into the rectum by using fingers or any mechanical device or applicator
• do not exceed recommended daily dosage unless directed by a doctor

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

-if the symptoms being treated do not subside or ir redness, irritation, swelling,

pain or other symptoms develop or increase. Some people can develop allergic

reactions to ingredients in this product.

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:

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gentlydry by patting or blotting with toilet tissue or a soft

cloth before application of this product.

-apply externally to the affected area up to 4 times daily especially at night r

in the morningor after each bowel movement.

hildren under 12 years of age: consult a doctor.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis leaf extract,

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
glycerin, phenylephrine hcl, pramoxine hcl, petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-004-02	1 in 1 BOX	03/14/2017
1	NDC: 69571-004-01	26 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	03/14/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-004)