FDA Label for Family Wellness
View Indications, Usage & Precautions
Family Wellness Product Label
The following document was submitted to the FDA by the labeler of this product Front Pharmaceutical Plc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
Hydrocortisone 1%
Otc - 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
Otc - 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
Otc - Questions
Questions? 1-800-638-3800 Weekdays 0 AM to 4 PM EST
Package Label.Principal Display Panel
* Please review the disclaimer below.