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

bioCorneum HC Advanced Scar Supervision Anti-Itch by

Drug Labeling and Warnings

bioCorneum HC Advanced Scar Supervision Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Enaltus Inc, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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

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

bioCorneum HC Advanced Scar Supervision Anti-Itch Gel 5g (

43474-000-05)

INGREDIENTS AND APPEARANCE

BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH 
hydrocortisone acetate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43474-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43474-000-05	1 in 1 CARTON
1		5 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	05/10/2012

Labeler - Enaltus Inc (038868036)

Registrant - Enaltus Inc (038868036)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	manufacture