HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream 
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 Cream

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:

•eczema      •insect bites      •poison ivy      •poison oak      •poison sumac      •soaps

•jewelry      •detergents       •cosmetics       •psoriasis          •seborrheic dermatitis

•for external genital, feminine and anal itching

•other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

When using this product

•avoid contact with the eyes   •do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:   •do not use more than directed unless directed by a doctor   

•do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

•symptoms last for more than 7 days   •the condition gets worse   •symptoms clear up and occur again in a few days   •rectal bleeding occurs, consult doctor promptly

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  •apply to affected area not more than 3 to 4 times daily
Children under 2 years of age   •do not use, consult a doctor  
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 issue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax.  May contain citric acid or sodium citrate solution to adjust pH.

Questions?  

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

PRINCIPAL DISPLAY PANEL

pdp

HYDROCORTISONE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45865-630(NDC:0472-0343)
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBIC ACID (UNII: X045WJ989B)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45865-630-011 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 finalpart34807/01/1997
Labeler - medsource pharmaceuticals (833685915)
Establishment
NameAddressID/FEIBusiness Operations
medsource pharmaceuticals833685915repack(45865-630)

Revised: 12/2018
Document Id: 7df0b4ca-2f58-e8e5-e053-2991aa0af9ee
Set id: 7df0b4dd-2798-e693-e053-2991aa0abacb
Version: 1
Effective Time: 20181226
 
medsource pharmaceuticals