HYDROCORTISONE- hydrocortisone cream 
Henry Schein

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570-3124 Hydrocortisone Cream 1% NDC 0404-0166-50

Active Ingredient

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)

Use(s)

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and for external genital, feminine, and anal itching.

Warnings

For External Use Only

If pregnant or breastfeeding, ask a health professional before use

Do not use

• In the eyes

• For diaper rash

• For external genital or feminine itching if you have a vaginal discharge

• More than the recommended daily dosage unless directed by a doctor

• In the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer that 7 days

• In case of bleeding when used for anal itching

Keep out of reach of children

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

Directions

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

• Children under 2 years of age: Consult a doctor

• When using for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with bathroom tissue or soft cloth befor applying

• Children under 12: Consult a doctor before using for anal itching

Other Information

• Store at room temperature 15º-30ºC (59º-86ºF)

• Avoid excessive heat

• Tamper Evident. Do not use if seal is damaged.

Inactive Ingredients

Cetostearyl Alcohol, Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions?

1-888-DYNAREX Monday-Friday, 9AM-5PM EST

Label

HS-570-3124 BX MASTERHydrocortisone Cream 1%

HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0166
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0166-5072 in 1 CASE11/07/2022
11 in 1 BOX
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03211/07/2022
Labeler - Henry Schein (012430880)

Revised: 1/2024
Document Id: 1041f6fe-d529-54a3-e063-6294a90ac0c3
Set id: eb031535-d17e-9d5e-e053-2a95a90ad3e0
Version: 2
Effective Time: 20240131
 
Henry Schein