ANTI-ITCH- hydrocortisone cream 
Medline Industries, LP

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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091 Curad Hydrocortisone 1% Cream Anti-itch

Active ingredient (in each gram)

Hydrocortisone 1%, USP

Purpose

Antipuritic (Anti Itch)

Uses

Warnings

Do not use and consult a doctor

  • for the treatment of diaper rash
  • if you have a vaginal discharge
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For external anal itching,

Other information

Inactive ingredients

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum.

Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.curad.com

1-800-633-5463

REF: CUR015431

V2 RA23GZP

Package Label

Label V2 RA23GZP

ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-091-011 in 1 BOX03/01/2010
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:53329-091-9148 in 1 CARTON03/01/2010
2NDC:53329-091-901.5 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:53329-091-96144 in 1 CASE03/01/2010
328.4 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:53329-091-901.5 g in 1 PACKET; Type 0: Not a Combination Product03/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2010
Labeler - Medline Industries, LP (025460908)
Registrant - Medline Industries, LP (025460908)

Revised: 8/2023
Document Id: 026de641-b235-cecc-e063-6394a90ad072
Set id: b0947381-c0db-4253-ab40-3d45603ae65d
Version: 11
Effective Time: 20230808
 
Medline Industries, LP