WL-AAC-Z-A-568- zinc oxide stick

WL-AAC-Z-A-568 by

Drug Labeling and Warnings

WL-AAC-Z-A-568 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WL-AAC-Z-A-568 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-4338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PHENYLPROPANOL (UNII: 0F897O3O4M)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
PROPANEDIOL (UNII: 5965N8W85T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-4338-1	3000 g in 1 PAIL; Type 0: Not a Combination Product	05/16/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/16/2019

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-4338)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-4338) , manufacture(63931-4338) , pack(63931-4338)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions		872684803	api manufacture(63931-4338)