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.

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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)

OuterPackage

InnerPackage

Label

Drug Facts

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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (HYDROCORTISONE)	HYDROCORTISONE ACETATE	1 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5
DIMETHICONE
DIMETHYL ISOSORBIDE
PENTYLENE GLYCOL
PROPYLENE GLYCOL
SILICON DIOXIDE

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:43474-000-05	1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON	contains a BOTTLE, PUMP
1		5 g in 1 BOTTLE, PUMP	This package is contained within the CARTON (43474-000-05)

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	Operations
Formulated Solutions, LLC		143266687	manufacture

Revised: 05/2012 Enaltus Inc