GADADERM HYDROCORTISONE- hydrocortisone acetate cream 
Gadal Laboratories 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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Active Ingredient                                   Purpose

Hydrocortisone Acetate (0.5%)       Antiruritic (Anti-itch)

Purpose

Antipruritic (Anti-itch)

Uses



For temporary relief of minor skin irritations and rashes due to eczema, insect bites, poison oak, poison sumac, poison ivy, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itchin. Other uses of this product should be only under the advice and supervision of doctor.

Warnings: For External Use Only.

Do not use

Stop use and ask a doctor if

Ask a doctor before use if you are pregnant or breast-feeding

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying. Apply externally to the area up to 6 times daily or after each bowel movement. After application, discard pad. Do not flush in toilet.

Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, propylparaben

GADAL Laboratories, Inc.

Miami, Fl 33186

www.gadallaboratories.com

hydrocortisone

GADADERM HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-262
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CETEARETH-6 (UNII: 2RJS3559D3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-262-011 in 1 BOX
142.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2013
Labeler - Gadal Laboratories Inc (841305639)

Revised: 9/2013
Document Id: 18d0cac1-584a-4679-8888-65051e73ebbd
Set id: 986317c2-5f75-406a-ae13-375d11b21a44
Version: 1
Effective Time: 20130905
 
Gadal Laboratories Inc