KELO-COTE HC Anti-Itch Scar Treatment

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Advanced Bio-Technologies, Inc
NDC Code: 40101-001

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.

KELO-COTE HC Anti-Itch Scar Treatment

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

Kelo-cote HC with 1% hydrocortisone acetate for itchy scars  Anti-Itch Scare Treatment  In a recent survey, 42% of respondents reported that their scars were itchy.3  In fact, itch is the most common symptom of keloid scars.4  Kelo-Cote HC was specifically developed with 1% hydrocortisone acetate to provide relief from itch caused by skin irritation and inflammation while treating your scar.  The foundation of this unique gel is Kelo-cote's patented silicone technology, which self-dries to form a flexible, breathable waterproof layer. Clinical studies have demonstrated that Kelo-cote helps flatten, soften, and reduce redness associated with scars, as well as help to relieve scar-related itch, pain, and discomfort. Kelo-cote may also help in the prevention of excessive and abnormal scar formations such as keloids.  It takes many months for your scar to completely mature. The combination of Kelo-cote's patented, proven silicone technology and the itch and inflammation relief provided by the 1% hydrocortisone acetate helps to create an optimal environment for scar maturation and an aesthetically pleasing end result. The convenience of a single product makes it simple to use.  - Kelo-cote HC is ideal for new and old scars that itch  - To help prevent abnormal scars from developing, use as soon as the wound is closed or sutures are removed  - This 10g tube is enough for 90 days effective treatment and itch relief for a scar size of 3-4 inches/7.5-10cm  US Patent No. 5,741,509  International Patents  Manufactured in the USA for:  ABT  Advanced Bio-Technologies, Inc.  Suwanee, GA 30024 USA  1 Radwanski H et. al. Rev Bras Cir Plast 2010; 25(3): 428-33.  2 Sepehrmanesh M. et. al. Komp Dermatol 2006; 30-32.  3 Data on file.  4 Shaffer JJ et. al. J Am Acad Dermatol. 2002 Feb;46 (2 Suppl Understanding): S63-97.  C 2011 Advanced Bio-Technologies, Inc.  7  92734 00416  3

Manufactured in the USA for:  ABT  Advanced Bio-Technologies, Inc.  Suwanee, GA 30024 USA - US Patent #5,741,509 and International Patents.   Kelo-cote  HC  with 1% hydrocortisone acetate for itchy scars  ABT Advanced Bio-Technologies, Inc.  NET WT 10g Gel

Kelo-cote HC with 1% hydrocortisone acetate for itchy scars  Anti-Itch Scare Treatment Manufactured in the USA for:  ABT  Advanced Bio-Technologies, Inc.  Suwanee, GA 30024 USA  C 2011 Advanced Bio-Technologies, Inc.

Advanced Formula Scar Gel  Kelo-cote  HC  with 1% hydrocortisone acetate for itchy scars  - Maximum strength itch relief  - Reduces redness  - Helps prevent excessive scar formation when used on new scars1  - Clinically proven to soften and flatten raised scars2  Recommended by physicians - Preferred by patients  ABT  Advanced Bio-Technologies, Inc.

Kelo-cote  HC  with 1% hydrocortisone acetate for itchy scars  NET WT 10g GEL  Kelo-cote  HC  Kelo-cote  HC  with 1% hydrocortisone acetate for itchy scars  NET WT 10g GEL  LOT  EXP.  KCGHC10US  KCGHC10USCB-1   7  92734 00416  3

Product Inner Package

Product Outer Package 1

Product Outer Package 2

Product Outer Package 3

KELO-COTE HC ANTI-ITCH SCAR TREATMENT 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40101-001
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 Description
1NDC:40101-001-001 TUBE (TUBE) in 1 CARTON
110 g in 1 TUBE
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/FEIOperations
Formulated Solutions, LLC143266687manufacture

Revised: 01/2012
 
Advanced Bio-Technologies, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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