Itch and rash cream cream

Indications & usage section

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 section

KEEP OUT OF REACH OF CHILDREN. iF SWALLOWED, get medical help or

contact a Poison Control Center right

away.

Warnings section

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 section

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 section

INACTIVE INGREDIENTS:CITRICacid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl

paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.

Otc - active ingredient section

ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG

Otc - purpose section

ANTIPRURITIC (ANTI-ITCH)

Ingredients and appearance - Product information

Itch and rash cream cream- Hydrocortisone

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 69103-4506
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Hydrocortisone ( UNII: WI4X0X7BPJ)( Hydrocortisone - UNII: WI4X0X7BPJ ) 10 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Glycerin ( UNII: PDC6A3C0OX)
Glyceryl monostearate ( UNII: 230OU9XXE4)
Methylparaben ( UNII: A2I8C7HI9T)
Petrolatum ( UNII: 4T6H12BN9U)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Propylparaben ( UNII: Z8IX2SC1OH)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Anhydrous trisodium citrate ( UNII: RS7A450LGA)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color white (SNOW WHITE)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Provision Medical Products( 036936831)

Establishment

Name ID/FEI Business Operations
Provision Medical Products 036936831 pack( 69103-4506)

Package label.principal display panel