HYDROCORTISONE- hydrocortisone cream 
DIRECT RX

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HYDROCORTISONE CREAM

Hydrocortisone 1%

Antipruritic (Anti-itch)

Relieves itches and rashes due to:

Eczema
Psoriasis
Seborrheic dermatitis
Poison ivy
Poison oak
Poison sumac
Insect bites
External anal itching
Soaps
Detergents
Cosmetics
Jewelry

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

For external use only

Do not use:

In the eyes
For diaper rash
If you have vaginal discharge
More than the recommended dosage

Ask doctor before use:

If you are pregnant or breast feeding

Stop use and ask a doctor if:

Condition worsens, or is 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.

​When using this product:

Do not put this product into rectum by using fingers or any mechanical device or applicator.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away

Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
Children under 2 years of age - Do not use. Consult a doctor.

For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. ​Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.

store between 20ºC and 25ºC (68ºFk and 77ºF)
avoid excessive heat and humidity

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

276

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-276(NDC:70512-101)
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
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CHLOROCRESOL (UNII: 36W53O7109)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CETETH-20 (UNII: I835H2IHHX)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72189-276-2828.4 g in 1 TUBE; Type 0: Not a Combination Product09/21/202110/09/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03209/21/202110/09/2023
Labeler - DIRECT RX (079254320)
Registrant - DIRECT RX (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DIRECT RX079254320relabel(72189-276)

Revised: 10/2023
 
DIRECT RX