The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Itch And Rash Cream (NDC 84269-4506). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, otc - active ingredient, otc - purpose, 1% hydrocortisone itch cream, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
KEEP OUT OF REACH OF CHILDREN. iF SWALLOWED, get medical help or
contact a Poison Control Center right
away.
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
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 INGREDIENTS:CITRIC acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl
paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.
ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG
ANTIPRURITIC (ANTI-ITCH)
* Please review the disclaimer below.
