HYDROCORTISONE- antipruritic (anti-itch) cream 
Dynarex Corporation

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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1137 Hydrocortisone Cream NDC 67777-003-01

Active Ingredient

Hydrocortisone Acetate 1%

Purpose

Antipruritic (Anti-Itch)

Uses

For 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 breast-feeding,

ask a health professional before use

Do not use

  • in the yes
  • 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
  • this product in the rectumby 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, and do not use this or any other hydrocortisone product.
  • in case of bleeding when used for anal itching

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Ceteareth-20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium Metabisulfite, Water, White Petrolatum

1137 Label

1137 BX MASTER

HYDROCORTISONE 
antipruritic (anti-itch) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
MINERAL OIL (UNII: T5L8T28FGP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-003-011728 in 1 CASE05/03/2018
1NDC:67777-003-02144 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 not finalpart34805/03/2018
Labeler - Dynarex Corporation (008124539)

Revised: 12/2022
Document Id: ef401189-5905-6c38-e053-2995a90a5704
Set id: 81ccb562-0cbc-07e4-e053-2a91aa0aaea3
Version: 6
Effective Time: 20221207
 
Dynarex Corporation