SCHEIN HYDROCORTISONE- hydrocortisone cream 
Henry Schein, Inc.

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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Drug Facts

Active Ingredients (in each gram): Hydrocortisone USP 10mg

Antipruritic (Anti-Itch)

Uses: For the temporary relief of itching associated with minor skin irritations, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatits, psoriasis, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor,

Warnings: For external use only. Avoid contact with the eyes.  Do not use and consult a doctor for the treatment of diaper rash, if you have a vaginal discharge. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Directions: For 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: Do not use, consult a doctor. For external anal itching, Adults: When practical, cleanse the affected area with mild soap and water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product. Children under 12 years of age: consult a doctor.

Inactive Ingredients: benzoic acid, chlorphenesin,  citric acid, glycerin, glycerol monostearate, methyl paraben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80,  purified water, titanium dioxide and trisodium citrate.

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

If pregnant or breast-feeding, ask a health professional before use.

hs hydro box

SCHEIN HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0370
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
BENZOIC ACID (UNII: 8SKN0B0MIM)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-0370-481 in 1 CARTON05/04/2015
1NDC:0404-0370-2828 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/201105/01/2022
Labeler - Henry Schein, Inc. (012430880)
Registrant - Ultra Seal Corporation (944090448)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(0404-0370)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation944090448pack(0404-0370)

Revised: 1/2023
 
Henry Schein, Inc.