HYDROCORTISONE D- hydrocortisone cream 
NexMed (USA), 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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Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Do not use


Keep out of reach of children

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

Directions

Other information

Store between 20 and 25C (68 to 77F)

Inactive Ingredients

citric acid, dodecyl-2-N N-dimethylaminopropionate hydrochloride, glycerin, glycerol stearate, methylparaben, petrolatum, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide

Questions?

Call 1-800-866-7391, Mon-Fri, 8:30 AM - 5:30 PM (PST)

image of carton and label
HYDROCORTISONE  D
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40002-003-021 in 1 CARTON
1NDC:40002-003-0328 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2011
Labeler - NexMed (USA), Inc. (031710528)
Registrant - NexMed (USA), Inc. (031710528)

Revised: 8/2011
Document Id: 5551bb51-cbd5-4ce2-94f5-15433eb899bc
Set id: 1df6f9ac-d564-4304-a99d-5056670be66f
Version: 1
Effective Time: 20110819
 
NexMed (USA), Inc.