WL-AAD-Z-W-1060- zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Nanophase Technologies Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

WL-AAD-Z-W-1060- 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-1060
WL-AAD-Z-W-1060 GHS LABEL
WL-AAD-Z-W-1060
zinc oxide lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 39 31-446 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
132 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
ALLANTO IN (UNII: 344S277G0 Z)
HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
SQ UALANE (UNII: GW8 9 575KF9 )
BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
.ALPHA.-BISABO LO L, ( +) - (UNII: 10 5S6 I733Z)
SO DIUM MYRISTO YL GLUTAMATE (UNII: AYU7QD8 9 3W)
ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )
WATER (UNII: 0 59 QF0 KO0 R)
NIACINAMIDE (UNII: 25X51I8 RD4)
PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)
METHYLPRO PANEDIO L (UNII: N8 F53B3R4R)
PHENYLPRO PANO L (UNII: 0 F8 9 7O3O4M)
SHEA BUTTER (UNII: K49 155WL9 Y)
ISO AMYL LAURATE (UNII: M1SLX0 0 M3M)
PO LYGLYCERYL-3 DIISO STEARATE (UNII: 46 P231IQV8 )
ISO PRO PYL ISO STEARATE (UNII: C6 7IXB9 Y7T)
PRODUCT CHARACTERISTICS
COLOR
bro wn
S CORE
S HAP E
S IZ E
FLAVOR
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 39 31-446 0 -1 150 0 0 0 mL in 1 DRUM; Type 0 : No t a Co
mbinatio n Pro duct
0 1/20 /20 21
Nanophase Technologies Corporation
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt352
0 1/20 /20 21
LAB