BIO-CORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH - hydrocortisone acetate gel 
Advanced Bio-Technologies, 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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BIO-CORNEUM HC Advanced Scar Supervision Anti-Itch Gel

Active ingredient

Active ingredient                                Purpose
Hydrocortisone acetate 1%................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

- in or near the eyes  - for the treatment of diaper rash: ask a doctor

Stop use and ask a doctor if

- condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions

- ensure that affected area is clean and dry  - apply evenly in a very thin layer to affected area not more than 3 to 4 times daily  - children under 2 years of age : consult a doctor

Other information

- store below 25 degree (77 degree F)

Inactive ingredients

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

Questions?

1-800-240-8227

Purpose

Anti-itch

Description

BioCorneum may reduce redness, soften and flatten scars, and prevent further damage caused by the sun.  Manufactured in the USA for:  Advanced Bio-Technologies, Inc.  Suwanee, GA 30024 USA   2011 Advanced Bio-Technologies, Inc.  7  92734 00560  3  EXP.  LOT

bioCorneum HC with 1% Hydrocortisone Acetate   advanced SCAR SUPERVISION Anti-Itch Gel NET WT 5g   Manufactured in the USA for:  Advanced Bio-Technologies, Inc.  Suwanee, GA 30024 USA   2011 Advanced Bio-Technologies, Inc.  BCPHUSLB-1

bioCorneum HC with 1% Hydrocortisone Acetate   advanced SCAR SUPERVISION Anti-Itch Gel NET WT 5g 

Product Inner Package

Inner Package

Product Outer Package

Outer Package

BIO-CORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH 
hydrocortisone acetate gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:40101-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
DIMETHICONE 
DIMETHYL ISOSORBIDE 
PENTYLENE GLYCOL 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40101-002-001 in 1 CARTON
15 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/02/2012
Labeler - Advanced Bio-Technologies, Inc (943947569)
Registrant - Advanced Bio-Technologies, Inc (943947569)
Establishment
NameAddressID/FEIBusiness Operations
Formulated Solutions, LLC143266687manufacture

Revised: 1/2012
 
Advanced Bio-Technologies, Inc