HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
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 MAXIMUM STRENGTH 1 percent

 Drug Facts

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:
•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

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 application of this product
Children under 12 years of age: consult a doctor

Other 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 or Comments?

1-800-632-6900

PRINCIPAL DISPLAY PANEL 

Kroger®
FROM OUR FAMILY TO YOURS

NDC 30142-343-56
COMPARE to the active ingredient in Cortaid® Maximum Strength Cream
*See Bottom Panel 

Hydrocortisone Cream, USP 1%
ANTI-ITCH CREAM
MAXIMUM STRENGTH  

For the Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation and Rashes Due to:
•Poison Ivy, Oak, Sumac   •Insect Bites    •External Genital, Feminine or Anal Itch
•Eczema   •Seborrheic Dermatitis 

NET WT 1 OZ (28 g)

Hydrocortisone Cream
HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-343
Route of Administration TOPICAL
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)  
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)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:30142-343-56 1 in 1 CARTON 07/24/2008
1 28 g in 1 TUBE; Type 0: Not a Combination Product
2 NDC:30142-343-57 1 in 1 CARTON 07/24/2008
2 56 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 07/24/2008
Labeler - Kroger Company (006999528)
Establishment
Name Address ID/FEI Business Operations
Encube Ethicals Pvt. Ltd 725076298 MANUFACTURE(30142-343)
Establishment
Name Address ID/FEI Business Operations
G&W NC Laboratories, LLC 079419931 MANUFACTURE(30142-343)

Revised: 7/2016
Document Id: 467f9ab4-df45-4827-b6f9-cb7a4338a536
Set id: 70960847-29fe-4c8b-80c9-3ea067a6cd8b
Version: 5
Effective Time: 20160708
 
Kroger Company