HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
The Kroger Company

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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Hydrocortisone Cream, USP 1%

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

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

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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

Children under 2 years of age

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 application of this product

Children under 12 years of age: consult a doctor

Other Information

•  Store at room temperature 59°-86°F (15°-30°C).  Protect from freezing.
•  Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive Ingredients

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?

1-800-632-6900

PRINCIPAL DISPLAY PANEL 

Compare to the active ingredient of CORTAID® INTENSIVE THERAPY CREAM.
*See Bottom Panel
Kroger®
maximum strength
HYDROCORTISONE CREAM, USP 1%
• Itch and Rash Relief • Antipruritic (Anti-Itch) Cream
For the Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation and Rashes Due to:
• Poison Ivy, Oak, Sumac • Insect Bites
• External Genital or Anal Itch • Eczema • Seborrheic Dermatitis
NET WT 1 OZ (28 g)

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HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-343
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
METHYLPARABEN 
SORBITAN MONOSTEARATE 
STEARYL ALCOHOL 
WHITE WAX 
POLYOXYL 40 STEARATE 
POLYSORBATE 60 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
SORBIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-343-561 in 1 CARTON
128 g in 1 TUBE
2NDC:30142-343-571 in 1 CARTON
256 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/24/2008
Labeler - The Kroger Company (006999528)
Establishment
NameAddressID/FEIBusiness Operations
Actavis Mid Atlantic LLC809515898ANALYSIS(30142-343), MANUFACTURE(30142-343)

Revised: 5/2013
Document Id: 06c34bc7-fd71-4d91-81b0-5241fcfa404f
Set id: 70960847-29fe-4c8b-80c9-3ea067a6cd8b
Version: 1
Effective Time: 20130515
 
The Kroger Company