THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE- hydrocortisone cream 
Veridian Healthcare

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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TheraCare Maximum Strength 1% 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

cetostearyl alcohol, edetate sodium, glyceryl monostearate, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, sorbitan monostearate water.

TheraCare Maximum Strength 1% Hydrocortisone Cream

Packlabel

THERACARE MAXIMUM STRENGTH 1% HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-211
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
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-211-011 in 1 CARTON05/01/2021
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 not finalpart34805/01/2021
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Private Limited916837425manufacture(71101-211)

Revised: 5/2021
Document Id: c18159e9-cad3-0384-e053-2995a90af492
Set id: c1815a19-f463-3c12-e053-2995a90a2607
Version: 1
Effective Time: 20210504
 
Veridian Healthcare