FDA Label for Family Wellness Maximum Strength Hydrocortisone
View Indications, Usage & Precautions
Family Wellness Maximum Strength Hydrocortisone Product Label
The following document was submitted to the FDA by the labeler of this product Family Dollar. 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 ingredient Purpose
Hydrocortisone, USP 1%.......................................Anti-Itch
Otc - Purpose
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- insect bites
- poison ivy
- poison oak
- poison sumac
- soaps
- jewelry
- detergents
- cosmetics
- psoriasis
- seborrhea dermatitis
- temporarily relieves external anal and genital itching
- other uses for this product should be only under the advice and supervision of a doctor
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
- in the genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
Otc - When Using
When using this product
- avoid contact with the eyes
- do not use more than directed unless told to do so by a doctor
- do not put this product into the rectum by using finger or any mechanical device or applicator
Otc - Stop Use
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.
Indications & Usage
Directions
- for itching of 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
Storage And Handling
Other information
- Store at room temperature 20°-25°C (68°-77°F)
- lot no. & exp. date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water
Dosage & Administration
Distributed By:
Family Dollar Services, Inc.
10401 Monroe Rd.
Matthews, NC 28105 USA
Made in Korea
Package Label.Principal Display Panel
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