ZINCTRAL- zinc oxide paste 
PureTek 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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Zinctral
Zinc Oxide 20% (3% as Calamine)

Active ingredient

Zinc Oxide 20.0%

(3.0% as Calamine)

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product 

  • do not get into eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of childern.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients:

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance (Contains: Alpha-Isomethyl Ionone, Butylphenyl Methylpropional, Coumarin, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool), GenRx Complex® [Consisting of: Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, DL-Alpha-Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract ], Petrolatum, Phenoxyethanol, Zea Mays (Corn) Starch.

Zinctral™

Manufactured in the USA by:

PureTek Corporation
Panorama City, CA 91402
For questions or information call toll-free: 877-921-7873

Label

ZINCTRAL 
zinc oxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-627
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
LEVOMENOL (UNII: 24WE03BX2T)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PETROLATUM (UNII: 4T6H12BN9U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GINGER (UNII: C5529G5JPQ)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-627-0557 g in 1 TUBE; Type 0: Not a Combination Product03/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/24/2023
Labeler - PureTek Corporation (785961046)

Revised: 3/2023
Document Id: de990834-00db-0c7a-e053-2995a90a7c37
Set id: de990834-00da-0c7a-e053-2995a90a7c37
Version: 1
Effective Time: 20230324
 
PureTek Corporation