DRITHO-CREME HP- anthralin cream 
Summers Laboratories Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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SUMMERS LABS - DRITHO (11086-037) - DELIST

COMPOSITION: CREAM CONTAINING ANTHRALIN U.S.P. 1.0%

A BASE OF WHITE PETROLATUM, SODIUM LAURYL SULFATE, CETOSTEARYL ALCOHOL, ASCORBIC ACID, SALICYLIC ACID, METHYLPARABEN AND PURIFIED WATER.

INDICATION

AN AID IN THE TOPICAL TREATMENT OF QUIESCENT OR CHRONIC PSORIASIS.

WARNING

FOR EXTERNAL USE ONLY.

AN AID IN THE TOPICAL TREATMENT OF PSORIASIS.

KEEP OUT OF THE REACH OF CHILDREN.

Drithocreme-1-CARTON

DrithoCreme-1-tube

DRITHO-CREME  HP
anthralin cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11086-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTHRALIN (UNII: U8CJK0JH5M) (ANTHRALIN - UNII:U8CJK0JH5M) ANTHRALIN1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11086-037-0150 g in 1 TUBE; Type 0: Not a Combination Product01/01/201312/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201312/31/2021
Labeler - Summers Laboratories Inc (002382612)

Revised: 10/2023
Document Id: 074cfc73-ce25-5fe4-e063-6394a90a307a
Set id: 4d624774-3618-423c-89bd-492f4795ad19
Version: 9
Effective Time: 20231009
 
Summers Laboratories Inc