HYDROCORTISONE - hydrocortisone acetate cream 
Choice Laboratories

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 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Uses:

For temporary relief of;
Itching and rashes due to;

and for external itching of;

Warnings:

For external use only

Do not use:

Stop use and ask a physician if:

Keep out of reach of children

Directions:

Adults and children over 2 years of age
Children under 2 years of age
Adults

Other information:

Inactive ingredients:

Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)

Principal Display Panel

Hydrocortisone Cream 1%

Hydrocortisone




HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63174-224
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63174-224-0172 in 1 CASE
128.3 g in 1 TUBE
2NDC:63174-224-0812 in 1 CASE
2425 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/02/2010
Labeler - Choice Laboratories (650070394)
Establishment
NameAddressID/FEIBusiness Operations
Choice Laboratories650070394manufacture

Revised: 2/2010
Document Id: d268b744-00fa-42e1-9275-ee17990c70f6
Set id: 0249c123-f4a2-4593-b81c-7295175ad6cb
Version: 1
Effective Time: 20100202
 
Choice Laboratories