CVS HEALTH HYDROCORTISONE ANTI ITCH- hydrocortisone cream 
CVS Health

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.

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Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

For external use only

Do not use

  • for the treatment of diaper rash, consult a doctor.
  • for external genital itching if you have a vaginal discharge, consult a doctor.

When using this product

  • avoid contact with eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

  • If condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.

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

Directions

Adults and children 2 years and older

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

  • do not use. Consult a doctor.

For external anal itching:

  • adults: when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • children under 12 years of age with external anal itching: consult a doctor.

Other information

store at a controlled room temperature 20 - 25ºC (68 - 77ºF).

Inactive ingredients

Aloe barbadensis leaf extract, Aluminum Sulfate, Beeswax, Calcium acetate, Cetearly alcohol, Dextrin, Glycerin, Maltodextrin, Methylparaben, Mineral oil , Petrolatum, propylparaben, Sodium cetearyl sulfate, Sodium lauryl sulfate, Water (purified)

Principal Display Panel – Packet Label

Principal Display Panel – Packet label

CVS Health NDC 69842-155-10

Cortisone MAXIMUM STRENGTH

Net Wt. 0.05 oz (1.5g) Hydrocortisone Cream USP 1%

Principal Display Panel – Carton Label

Principal Display Panel – 1oz Tube Label

compare to the active ingredient in Cortisone 10®

CVS Health  NDC 69842-155-10

Cortisone MAXIMUM STRENGTH

Net Wt. 1.2 oz (36g) Hydrocortisone Cream USP 1%



CVS HEALTH HYDROCORTISONE ANTI ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-155
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM SULFATE (UNII: 34S289N54E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM ACETATE (UNII: Y882YXF34X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
ICODEXTRIN (UNII: 2NX48Z0A9G)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-155-1024 in 1 CARTON04/28/2017
11.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/28/2017
Labeler - CVS Health (062312574)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(69842-155)

Revised: 4/2017
Document Id: f2d069a5-01ea-4533-bdf2-0c6c8cfd01a7
Set id: 546a1b8a-8254-432a-85c4-38ebee5ad568
Version: 1
Effective Time: 20170428
 
CVS Health