HYDROCORTISONE  - hydrocortisone cream 
Morales Distributors Inc

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

Active ingredient

Hydrocortisone 1.0 percent

Purpose

Anti-Itch

Uses

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to

Other uses of this product: ask a doctor

Warnings

For external use only

Do not use

Ask a doctor or pharmacist

before use if you are using any other hydrocortisone product

When using this product

for external anal itching, do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control

Directions

Other information

store at room temperature, protect from freezing

Inactive ingredients

butylated hydroxytoluene, cetyl alcohol, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, propylparaben, purified water, squalane, and stearic acid

Principal Label

NDC NO. 53210-1002-0
Compare to maximum strength Cortaid(R) active ingredient

Maximum Strength
FAST RELIEF
plus itching plus redness

Anti-Itch Cream for Skin Irritations

Relieves Itching and Redness Fast

Hydrocortisone 1 percent Cream

NET 1oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pharmacia Consumer Healthcare, owner of the registered trademark Cortaid.(R)

Made in Korea

box label

box label

tube label

HYDROCORTISONE  
hydrocortisone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53210-1002
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
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53210-1002-0 1 in 1 BOX
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/25/2012
Labeler - Morales Distributors Inc (127151731)

Revised: 9/2012
Document Id: 71b8d41c-4468-448a-8cb6-5f03b0852596
Set id: 1c767101-c2e9-4c66-bca5-b7a7991e3a2c
Version: 5
Effective Time: 20120928
 
Morales Distributors Inc