HYDROCORTISONE- hydrocortisone acetate cream 
A-S Medication Solutions

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

Active Ingredient (in each gram): Hydrocortisone Acetate 10mg (equivalent to Hydrocortisone 1%)

Purpose: anti-itch cream

Warnings: For external use only. Do not get in eyes

Allergy alert: A severe allergic reaction to insect bites or stings may require life support measures. In such cases, immediately clal 911 or your local emergency provider.

Do not use:

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. 1-800-222-1222

Directions:

Adults and children 12 years of age and over: apply topically to the area 3 to 4 times daily.

Children under 12 years of age: do not use, ask a doctor

Inactive Ingredients: Cetyl Alcohol, Citric Acid, Diazolidinyl Urea, Edetate Disodium, Glycerin, Glyceryl Monostearate, Methylparaben, Mineral Oil, Polyethylene Glycol, Propylene Glycol, Propylparaben, Purified Water, Stearic Acid, Trolamine

HOW SUPPLIED

Product: 50090-4456

NDC: 50090-4456-0 .9 g in a PACKET / 10 in a BOX, UNIT-DOSE

HYDROCORTISONE ACETATE

Label Image
HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4456(NDC:50332-0042)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50090-4456-010 in 1 BOX, UNIT-DOSE08/05/2019
1.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/1990
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-4456)

Revised: 10/2019
Document Id: 45bc24df-2f33-4055-b4d4-23bf9ef3f338
Set id: a584d3ad-9a00-4acc-bf73-6a3cd509b053
Version: 1
Effective Time: 20191014
 
A-S Medication Solutions