REGULAR STRENGTH HYDROCORTISONE CREAM- hydrocortisone cream cream 
Walgreens

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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Active Ingredient

Hydrocortisone, USP 0.5%

Purpose

Anti-itch

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, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, for external genital, feminine and anal itching, 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 external feminine itching if you have a vaginal discharge.  Consult a doctor.

for the treatment of diaper rash.  Consult a doctor.

When using this product

avoid contact with the eyes, do not begin the use of any other hydrocortisone product unless directed by a doctor, for external anal itching: do not use more than directed unless directed by 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

symptoms last for more than 7 days, the condition gets worse, symptoms clear up and occur again in a few days, rectal bleeding occurs, consult doctor promptly

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 of age 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, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before applicaion of this product.

Children under 12  years of age: consult a doctor.

Other information

Storage temperature: not to exceed 30oC (86oF).  Protect from freezing.

Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water.  May contain citric acid or sodium citrate solution to adjust pH. 

Carton Label

Carton LabelCarton Label

Tube Label

Tube LabelTube Label

REGULAR STRENGTH HYDROCORTISONE CREAM 
hydrocortisone cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0639
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.51 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 79.79 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 g
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 7 g  in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X) 4 g  in 100 g
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) 0.5 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.2 g  in 100 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 1.5 g  in 100 g
PEG-40 STEARATE (UNII: ECU18C66Q7) 0.5 g  in 100 g
BENZYL ALCOHOL (UNII: LKG8494WBH) 1 g  in 100 g
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 4 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0639-031 in 1 CARTON06/07/2016
1NDC:0363-0639-0156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/07/2016
Labeler - Walgreens (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(0363-0639)

Revised: 10/2020
Document Id: f3e376d6-532f-4b3e-9730-77f6a5ac2ead
Set id: f872781e-6571-4295-8ab6-1455f0b823df
Version: 9
Effective Time: 20201029
 
Walgreens