NDC 59088-852-08
API & Excipient Details

marketed by PureTek Corporation under NDC Code 59088-852-08

NDC Code(s) : 59088-852-01, 59088-852-69, 59088-852-08
Packager : PureTek Corporation

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GenRx Cala Zinc Skin HealingZinc Oxide PASTE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:59088-852
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
KUKUI NUT OIL(UNII: TP11QR7B8R)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
SAFFLOWER OIL(UNII: 65UEH262IS)
LEVOMENOL(UNII: 24WE03BX2T)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
CARTHAMUS TINCTORIUS SEED OLEOSOMES(UNII: 9S60Q72309)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
NIACINAMIDE(UNII: 25X51I8RD4)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
GINGER(UNII: C5529G5JPQ)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(UNII: 461P5CJN6T)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)(UNII: 255PIF62MS)
PETROLATUM(UNII: 4T6H12BN9U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59088-852-69	144 in 1 CARTON
1	NDC:59088-852-01	4 mL in 1 POUCH
2	NDC:59088-852-08	118 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/08/2013

PRINCIPAL DISPLAY PANEL