FAMILY WELLNESS- hydrocortisone 1% 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

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

temporarily relieves itching associated with minor skin

irritations, inflammation and rashes due to:

   eczema  psoriasis  poison ivy, oak, sumac

   insect bites  detergents  jewelry

   cosmetics  soaps  saborrheiic dermatitis

temproarily relieves external and genital itching

other uses of this product should be under advice and

supervision of a doctor

WARNINGS

Warnings  For external use only.

Do not use:

in the genital area if you have vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

When using this product:

avoid contact with eyes.

do not use more than directed unless told to do so by a doctor.

do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days

or clear up and occur again within a few days, and do not

begin use of any other hydrocortisone product unless you

have asked a doctor  rectal bleeding occurs

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

for itching or skin irritation, inflammation and rashes:

   adults and children 2 years of age and older: apply to

   affected area not more than 3 to 4 times daily

   children under 2 years of age: ask a doctor

for external and genital itching, adults:

   when practical, clean the affected area with mild soap

   and warm waterand rinse thoroughly

   gently dry by patting or blotting with toilet tissue or soft

   cloth before applying

   apply to affected area not more than 3 to 4 times daily

   children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients aloe barbadensis leaf juice,

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

QUESTIONS

Questions?  1-800-638-3800  Weekdays 0 AM to 4 PM EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-009-01	1 in 1 CARTON	06/18/2017
1		28 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 not final	part348	06/18/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-009)