ITCH AND RASH CREAM- hydrocortisone cream

Itch and Rash Cream by

Drug Labeling and Warnings

Itch and Rash Cream by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

ACTIVE INGREDIENT

ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG

PURPOSE

ANTIPRURITIC (ANTI-ITCH)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ITCH AND RASH CREAM 
hydrocortisone cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-4506-3	25 in 1 CARTON	04/03/2015
1		.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-4506)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-4506)