WL-AAD-Z-W-2063 by Nanophase Technologies Corporation WL-AAD-Z-W-2063

WL-AAD-Z-W-2063 by

Drug Labeling and Warnings

WL-AAD-Z-W-2063 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAD-Z-W-2063- zinc oxide lotion 
Nanophase Technologies Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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WL-AAD-Z-W-2063

WL-AAD-Z-W-2063

WL-AAD-Z-W-2063 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63931-2063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+/-)- (UNII: 9MC3I34447)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
RUTIN (UNII: 5G06TVY3R7)
JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
FERROUS OXIDE (UNII: G7036X8B5H)
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
TOCOPHEROL (UNII: R0ZB2556P8)
SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO-CAPRYLATE (UNII: 4828G836N6)
NYLON-12 (UNII: 446U8J075B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
ALLANTOIN (UNII: 344S277G0Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
PROPANEDIOL (UNII: 5965N8W85T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
JOJOBA OIL (UNII: 724GKU717M)
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63931-2063-1	150000 mL in 1 DRUM; Type 0: Not a Combination Product	08/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/30/2023

Labeler - Nanophase Technologies Corporation (623502044)

Registrant - Nanophase Technologies Corporation (623502044)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		050383046	api manufacture(63931-2063)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		623502044	api manufacture(63931-2063) , manufacture(63931-2063)

Establishment
Name	Address	ID/FEI	Business Operations
Nanophase Technologies Corporation		118812921	manufacture(63931-2063) , pack(63931-2063)

Revised: 8/2023

Document Id: 042268d3-747a-3cbb-e063-6294a90a5452

34390-5

Set id: 0422a5a3-b188-cec6-e063-6294a90a5c02

Version: 1

Effective Time: 20230830