PS-2896 HYDROCORTISONE CREAM 1%, 0.9G- ps-2896 hydrocortisone cream 1%, 0.9g cream 
ProStat First Aid LLC

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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PS-2896 Hydrocortisone Cream 1%, 0.9g

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 external genital, feminine, and anal itching

Warnings

For External Use Only

If pregnant or breast-feeding

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 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 between 15º-30ºC (59º-86ºF) • Avoid excessive heat • Tamper evident. Do not use if packet is torn, cut, or opened

Inactive Ingredient

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

Questions?

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

Label

PS-2896 MC MASTERPS-2896 Hydrocortisone Cream 1%, 0.9g

PS-2896 HYDROCORTISONE CREAM 1%, 0.9G 
ps-2896 hydrocortisone cream 1%, 0.9g cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58228-2896
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
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58228-2896-12000 in 1 CARTON07/31/2023
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 not finalpart34807/31/2023
Labeler - ProStat First Aid LLC (061263699)
Registrant - Dynarex Corporation (008124539)

Revised: 7/2023
Document Id: 0074e7bf-8c63-a5a7-e063-6394a90a63fc
Set id: 0074e7bf-8c62-a5a7-e063-6394a90a63fc
Version: 1
Effective Time: 20230714
 
ProStat First Aid LLC