HYDROCORTISONE- antipruritic (anti-itch) cream 
Dynarex Corporation

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1137 Hydrocortisone 1% Cream NDC 67777-004-04
1139 Hydrocortisone 1% Cream NDC 67777-004-01
1137UB-6 Hydrocortisone 1% Cream NDC 67777-004-05
1137-25 Hydrocortisone 1% Cream NDC 67777-004-07

Active Ingredients

Hydrocortisone USP 1%

Purpose

Antipruritic (Anti-Itch)

Uses

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 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

Other Information

Inactive Ingredients

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

Label

1137 BX MASTER

Label

1139 BX MASTER

Label 1137UB-6

1137UB-6_BX_MASTER1137UB-6

Label 1137-25

1137-25 BX_MASTER1137-25

HYDROCORTISONE 
antipruritic (anti-itch) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-004
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Product Characteristics
Color    Score    
ShapeFREEFORMSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-004-0412 in 1 CASE03/25/2021
1NDC:67777-004-03144 in 1 BOX
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:67777-004-0172 in 1 CASE03/25/2021
2NDC:67777-004-021 in 1 BOX
228.4 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:67777-004-05600 in 1 CASE03/25/2021
3NDC:67777-004-066 in 1 BOX
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:67777-004-071800 in 1 CASE03/25/2021
4NDC:67777-004-0825 in 1 BOX
40.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03203/25/2021
Labeler - Dynarex Corporation (008124539)

Revised: 1/2024
Document Id: 0fa32e68-a566-6d7e-e063-6394a90af08b
Set id: 81dff9df-6f7e-49f0-e053-2a91aa0af7e7
Version: 6
Effective Time: 20240123
 
Dynarex Corporation