HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone ointment 
medsource pharmaceuticals

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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Hydrocortisone Ointment Maximum Strength - Actavis

Drug Facts


Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

Children under 2 years of age

For external anal itching
Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product 
Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

mineral oil, white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

PRINCIPAL DISPLAY PANEL

pdp

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-906(NDC:0472-0345)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-906-011 in 1 CARTON06/01/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/21/1998
Labeler - medsource pharmaceuticals (833685915)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-906)

Revised: 12/2018
Document Id: 7d647b90-9e19-d650-e053-2991aa0aa676
Set id: 7d648449-6064-c084-e053-2991aa0a79cc
Version: 1
Effective Time: 20181219
 
medsource pharmaceuticals