HYDROCORTISONE - hydrocortisone cream 
CVS Pharmacy

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

drug facts

Active ingredient                            Purpose

Hydrocortisone 1%.................................... Anti-itch cream



Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor


Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center immediately.

Uses

temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:

- eczema - insect bites - poison ivy, poison oak or poison sumac - soaps - detergents - cosmetics
- jewlery - seborrheic dermatitis - psoriasis - other uses of this product: ask a doctor

Other information

- store at room temperature. Protect from freezing and excessive heat.
- see carton or tube crimp for lot number and expiration date.

Warnings

For external use only.

Do not use:
- in the eyes - for the treatment of diaper rash

Ask a doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

- condition worsens, or if symptoms persist for more than 7 days

- symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.


Directions 


- adults and children 2 years and older:apply to affected area not more than 3 to 4 times daily
- children under 2 years:do not use, ask a doctor

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa kernal flour oat, beeswax, cetyl alcohol, citric acid,
glyceryl stearate, isopropyl myristate, methylparaben, PEG-40 stearate, polysorbate 60,
propylene glycol, propylparaben, purified water, sodium citrate, sodium stearate, sorbic acid,
stearyl alcohol, tocopheryl acetate

c


HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-322
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
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
SORBIC ACID (UNII: X045WJ989B)  
SODIUM STEARATE (UNII: QU7E2XA9TG)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
WHITE WAX (UNII: 7G1J5DA97F)  
OATMEAL (UNII: 8PI54V663Y)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-322-201 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2009
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: 8eed5c4e-8e20-43f6-88b2-a04be7c50a6f
Set id: 7a02b713-df10-435d-acd5-3f9e6c2bea02
Version: 1
Effective Time: 20110216
 
CVS Pharmacy