HYDROCORTISONE CREAM 1%- hydrocortisone cream 1% cream 
Front Line Safety

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FL-2045

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 with a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days)

• Bleeding occurs due to 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 used for anal itching, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before 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 packet is torn, cut or opened.

Inactive Ingredients

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

Questions?

1-888-900-2920 Monday - Friday, 8AM - 4PM PST

Label

FL-2045_BX_MASTERFL-2045

HYDROCORTISONE CREAM 1% 
hydrocortisone cream 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-6245
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
WATER (UNII: 059QF0KO0R)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
TROLAMINE (UNII: 9O3K93S3TK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-6245-11800 in 1 CASE01/26/2024
125 in 1 BOX
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03201/26/2024
Labeler - Front Line Safety (061263699)

Revised: 1/2024
Document Id: 0f4ede34-7e71-789e-e063-6394a90a72a4
Set id: 0f4ede34-7e70-789e-e063-6394a90a72a4
Version: 1
Effective Time: 20240119
 
Front Line Safety