ITCH AND RASH CREAM- hydrocortisone cream 
Provision Medical Products

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1% Hydrocortisone Itch Cream

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)

1% Hydrocortisone Itch Cream

HYDRO POUCH

ITCH AND RASH CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-4506
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (SNOW WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-4506-325 in 1 CARTON04/03/201507/01/2024
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/31/201507/01/2024
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture(69103-4506)

Revised: 3/2024
Document Id: 14947f53-e4a3-3267-e063-6394a90ad34c
Set id: 627b9ff5-5cc4-4abc-98f1-9650f41b7a67
Version: 6
Effective Time: 20240326
 
Provision Medical Products