FDA Label for Itch And Rash Cream
View Indications, Usage & Precautions
Itch And Rash Cream Product Label
The following document was submitted to the FDA by the labeler of this product Provision Medical Products. 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.
Indications & Usage
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, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and
scrapes
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.
Warnings
Warnings :
For external use only Do not use for the treatment of diaper rash
Consult a doctor:before use if you have a vaginal discharge (for external feminine itching):
for external itching, do not exceed the recommended daily dosage or if bleeding occurs
if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
When using this product:avoid contact with eyes, do not put this product into rectum by using fingers or any mechanical
Do not use:with any other Hydrocortison product unless you have consulted a doctor
Dosage & Administration
dIRECTIONS: fOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER-APPLY TO AFFECTED AREA NOT MORE THAN 3 OR 4 TIMES DAILY
CHILDREN UNDER 2 YEARS, DO NOT USE, CONSULT A DOCTOR. ADULTS FOR EXTERNAL ANAL ITCHING WHEN PRACTICAL-CLEANSE THE AFFECTED AREA WITH A MILD SOAP AND WARM WATER AND RINCE THOROUGHLY OR BY PATTING AND BLOTTING WITH AN APPROPRIATE CLEANSING PAD. GENTLY DRY BY PATTING OR BLOTTING WITH A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT. CHILDREN UNDER 12 YEARS OF AGE-FOR EXTERNAL ANAL ITCHING, CONSULT A DOCTOR
Inactive Ingredient
INACTIVE INGREDIENTS:CITRIC acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl
paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.
Otc - Active Ingredient
ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG
Otc - Purpose
ANTIPRURITIC (ANTI-ITCH)
Package Label.Principal Display Panel
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