WL-AAB-Z-W-330- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

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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
Authorization number:
63931-4322-1

WL-AAB-Z-W-330- 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-AAB-Z-W-330

WL-AAB-Z-W-330

WL-AAB-Z-W-330

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 31-4322

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

PALMITO YL TETRAPEPTIDE-7 (UNII: Q41S46 4P1R)

TRILAURETH-4 PHO SPHATE (UNII: M9 6 W2OLL2V)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

O CTYLDO DECYL NEO PENTANO ATE (UNII: X8 725R8 8 3T)

ISO DO DECANE (UNII: A8 28 9 P6 8 Y2)

.ALPHA.-BISABO LO L, ( +) - (UNII: 10 5S6 I733Z)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

WATER (UNII: 0 59 QF0 KO0 R)

NIACINAMIDE (UNII: 25X51I8 RD4)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NO L/PRO PYLSILSESQ UIO XANE/SILICATE CRO SSPO LYMER ( 4 50 0 0 0 0 0 0 MW) (UNII: 9 KB5R9 58 PB)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

TETRASO DIUM GLUTAMATE DIACETATE (UNII: 5EHL50 I4MY)

CARRAGEENAN (UNII: 5C6 9 YCD2YJ)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PALMITO YL TRIPEPTIDE-1 (UNII: RV743D216 M)

.BETA.-TO CO PHERO L (UNII: 9 U6 A49 0 50 1)

PO LYMETHYLSILSESQ UIO XANE ( 4 .5 MICRO NS) (UNII: 59 Z9 0 7ZB6 9 )

Product Characteristics

Color

pink

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 31-4322-1 150 0 0 0 mL in 1 DRUM; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 9 /20 19

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 5/0 9 /20 19

Nanophase Technologies Corporation

Labeler -

Nanophase T echnologies Corporation (623502044)

Registrant -

Nanophase T echnologies Corporation (623502044)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies Co rpo ratio n

0 50 38 30 46

api manufacture(6 39 31-4322)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Nano phase Techno lo gies

Co rpo ra tio n

6 2350 20 44

api manufacture(6 39 31-4322) , manufacture(6 39 31-4322) , pack(6 39 31-

4322)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Amco l Health & Beauty So lutio ns

8 726 8 48 0 3

api manufacture(6 39 31-4322)

Revised: 5/2019

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