HYDROCORTISONE- hydrocortisone acetate cream 
HART Health

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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: emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Hydrocortv24f.jpgHydrocortv24f.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) HYDROCORTISONE ACETATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0042-110 in 1 BOX, UNIT-DOSE01/01/1974
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0042-710 in 1 BAG01/01/2000
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0042-225 in 1 BOX, UNIT-DOSE01/01/1974
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:50332-0042-4144 in 1 BOX, UNIT-DOSE01/01/1974
40.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01/01/1974
Labeler - HART Health (069560969)

Revised: 2/2024
Document Id: 25d82d74-ad85-4285-b25d-dbd59d7bdb1e
Set id: 779f945f-ab69-40de-8d86-ab76debc5c7c
Version: 5
Effective Time: 20240216
 
HART Health