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bioCorneum HC Advanced Scar Supervision Anti-Itch

Medically reviewed on May 16, 2018

Dosage form: gel
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Enaltus Inc
NDC Code: 43474-000

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
  • 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)



BIOCORNEUM HC ADVANCED SCAR SUPERVISION ANTI-ITCH 
hydrocortisone acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43474-000
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:43474-000-051 BOTTLE, PUMP (BOTTLE) 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/FEIOperations
Formulated Solutions, LLC143266687manufacture

 
Enaltus Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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