20PERCENT ZINC OXIDE NON TINTED- zinc oxide cream

20Percent Zinc Oxide Non Tinted by

Drug Labeling and Warnings

20Percent Zinc Oxide Non Tinted by is a Otc medication manufactured, distributed, or labeled by JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION, Custom Analytics LLC, Fragrance Manufacturing INC, Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

PURPOSE

INDICATIONS & USAGE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

OTHER SAFETY INFORMATION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

20PERCENT ZINC OXIDE NON TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85585-205(NDC:58892-205)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WATER (UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85585-205-15	1.5 g in 1 PACKET; Type 0: Not a Combination Product	03/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/23/2021

Labeler - JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION (557562910)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(85585-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing INC		793406000	manufacture(85585-205)

Establishment
Name	Address	ID/FEI	Business Operations
Fallien Cosmeceuticals Ltd.		958388357	relabel(85585-205)