THERACARE HYDROCORTISONE CREAM- hydrocortisone cream 
Veridian Healthcare

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TheraCare Hydrocortisone Cream

Active Ingredient:

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Do not use

  • in the genital area if you have a vaginal discharge.
  • for the treatment of diaper rash.
  • with any other hydrocortisone product unless you have asked a doctor

When using this product

  • use only as directed
  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Other information

Store at 20-25C (68-77F)

do not use if tube seal under cap is broken

Inactive Ingredients


ceteareth-20, cetearyl alcohol, ethylhexylglycerin, glycerin, glyceryl 1-stearate, mineral oil, phenoxyethanol, water, white petrolatum

TheraCare Hydrocortisone Cream

labelPack

THERACARE HYDROCORTISONE CREAM 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
MINERAL OIL (UNII: T5L8T28FGP)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-220-011 in 1 CARTON07/01/2023
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/01/2023
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Nantong Health & Beyond Hygienic Products Inc.421280161manufacture(71101-220)

Revised: 5/2024
Document Id: 18faaa71-8206-14c1-e063-6294a90a153f
Set id: 01cb7b47-2c3c-707d-e063-6294a90a5d97
Version: 3
Effective Time: 20240521
 
Veridian Healthcare