DRITHO-CREME HP- anthralin cream

DRITHO-CREME by

Drug Labeling and Warnings

DRITHO-CREME by is a Prescription medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

INDICATIONS & USAGE

INDICATION

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

WARNINGS

WARNING

FOR EXTERNAL USE ONLY.

PURPOSE

AN AID IN THE TOPICAL TREATMENT OF PSORIASIS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRITHO-CREME  HP
anthralin cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11086-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTHRALIN (UNII: U8CJK0JH5M) (ANTHRALIN - UNII:U8CJK0JH5M)	ANTHRALIN	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-037-01	50 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2013

Labeler - Summers Laboratories Inc (002382612)

Establishment
Name	Address	ID/FEI	Business Operations
Summers Laboratories Inc		002382612	manufacture(11086-037)