HYDROCORTISONE CREAM

HYDROCORTISONE CREAM

Drug Labeling and Warnings

Drug Details

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HYDROCORTISONE- hydrocortisone acetate cream 
HART Health

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:

  • in the eyes or over large portions of the body
  • for the treatment of diaper rash
  • with any other hydrocortisone product

Stop use and ask a doctor if:

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms 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 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

Hydrocort.jpg

Hydrocort.jpg

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50332-0042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 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: 50332-0042-110 in 1 BOX, UNIT-DOSE
10.9 g in 1 PACKET
2NDC: 50332-0042-225 in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC: 50332-0042-4144 in 1 BOX, UNIT-DOSE
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/1990
Labeler - HART Health (069560969)

Revised: 11/2012
 
HART Health


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