Lindane (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lindane Shampoo Carton

MGP

NDC 60432-834-60

LINDANE

SHAMPOO,

USP 1%

POISON: FOR EXTERNAL USE ONLY

HARMFUL OR FATAL IF SWALLOWED

WARNING: KEEP OUT OF

REACH OF CHILDREN

SAFETY SEALED BOTTLE

Rx Only

NET: 2 fl oz (60 mL)

LINDANE lindane shampoo, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-834 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LINDANE (LINDANE) LINDANE 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength TRIETHANOLAMINE LAURYL SULFATE POLYSORBATE 60 HYDROCHLORIC ACID ACETONE WATER

Product Characteristics Color YELLOW (Pale Yellow) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60432-834-60 60 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088191 09/18/1984

Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)

Establishment
Name	Address	ID/FEI	Operations
Morton Grove Pharmaceuticals, Inc.		801897505	ANALYSIS (60432-834), LABEL (60432-834), MANUFACTURE (60432-834), PACK (60432-834)

Revised: 12/2020 Morton Grove Pharmaceuticals, Inc.