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 Type HUMAN OTC DRUG Item Code (Source) NDC:30142-343
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-343-56 1 in 1 CARTON
1 28 g in 1 TUBE
2 NDC:30142-343-57 1 in 1 CARTON
2 56 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 07/24/2008
Labeler - The Kroger Company (006999528)
Establishment
Name Address ID/FEI Business Operations
Actavis Mid Atlantic LLC 809515898 ANALYSIS(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