OTC Medication Information: WL-AAD-Z-W-772

WL-AAD-Z-W-772- 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.

WL-AAD-Z-W-772 GHS Label

GHS label (Bulk)
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WL-AAD-Z-W-772
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63931-4413
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 132 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PALMITOYL TRIPEPTIDE-1
LECITHIN, SOYBEAN
TRIDECYL SALICYLATE
ALLANTOIN
SILICON DIOXIDE
SQUALANE
BUTYLOCTYL SALICYLATE
.ALPHA.-BISABOLOL, (+)-
PROPANEDIOL
SODIUM CHLORIDE
CAPRYLYL GLYCOL
PHENYLPROPANOL
SHEA BUTTER
ISOAMYL LAURATE
POLYGLYCERYL-3 DIISOSTEARATE
TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE, DL-
NYLON-12
TETRASODIUM GLUTAMATE DIACETATE
WATER
PALMITOYL TETRAPEPTIDE-7
POLYSORBATE 20
ALKYL (C12-15) BENZOATE
CAMELLIA SINENSIS FLOWER
CARRAGEENAN
COCO-CAPRYLATE/CAPRATE
GLYCERIN
UBIQUINONE Q2
POLYGLYCERYL-3 RICINOLEATE
ASCORBYL PALMITATE
BUTYLENE GLYCOL
C15-19 ALKANE
HYALURONATE SODIUM
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63931-4413-1 150000 mL in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/26/2021
Labeler — Nanophase Technologies Corporation (623502044)
Registrant — Nanophase Technologies Corporation (623502044)
Establishment
Name Address ID/FEI Operations
Nanophase Technologies Corporation 050383046 api manufacture (63931-4413)
Establishment
Name Address ID/FEI Operations
Nanophase Technologies Corporation 623502044 manufacture (63931-4413), api manufacture (63931-4413), pack (63931-4413)
Establishment
Name Address ID/FEI Operations
Amcol Health & Beauty Solutions 872684803 api manufacture (63931-4413)

Revised: 09/2021 Nanophase Technologies Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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