BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH - hydrocortisone acetate gel 
Enaltus 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.

----------

bioCorneum HC Advanced Scar Supervision Anti-Itch Gel

Active ingredient


Hydrocortisone acetate 1%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, soaps, detergents and cosmetics.

Warnings

For external use only

Do not use

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethyl Isosorbide, Pentylene Glycol, Propylene Glycol, Silicon Dioxide

Manufactured in the USA for: enaltus Suwanee, GA 30024 USA 2012 enaltus


bioCorneum HC Advanced Scar Supervision Anti-Itch Gel 5g (43474-000-05)


OuterPackage


InnerPackage


Label

Drug Facts

BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH 
hydrocortisone acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43474-000
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
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43474-000-051 in 1 CARTON
15 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34805/10/2012
Labeler - Enaltus Inc (038868036)
Registrant - Enaltus Inc (038868036)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture

Revised: 5/2012
Document Id: 98ee4d74-8e11-41e3-ad0c-0a7f089b3725
Set id: cae7655c-6595-4639-ab94-2f96575ce6cf
Version: 2
Effective Time: 20120516
 
Enaltus Inc