PREPARATION H SOOTHING RELIEF ANTI-ITCH- hydrocortisone cream 
Haleon US Holdings LLC

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Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Do not usefor the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store at 20–25°C (68–77°F)

Inactive ingredients

anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

PRINCIPAL DISPLAY PANEL - 26 g Tube Label

PREPARATION H ®

soothing
RELIEF
anti-itch cream

HYDROCORTISONE 1%

Maximum Strength
Without a Prescription

Effective Itch Relief

No Added Fragrance

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Label

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

NEW!

PREPARATION H ®

soothing
RELIEF
anti-itch cream

HYDROCORTISONE 1%

Maximum Strength
Without a Prescription

Effective Itch Relief

No Added Fragrance

ONE TUBE / NET WT 0.9 0Z (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PREPARATION H SOOTHING RELIEF ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0552
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL OLEATE (UNII: 4PC054V79P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PETROLATUM (UNII: 4T6H12BN9U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (off-white viscous cream) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-0552-111 in 1 CARTON02/28/2020
126 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01502/28/2020
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 12ad4740-7bcb-f822-e063-6394a90a0e38
Set id: d6148d77-ef6f-4552-b5ba-43b429923f19
Version: 6
Effective Time: 20240302
 
Haleon US Holdings LLC