Label: ZINCTRAL- zinc oxide paste
- NDC Code(s): 59088-627-05
- Packager: PureTek Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 24, 2023
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- Official Label (Printer Friendly)
- Active ingredient
- Uses
- Warnings
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Directions
- Cleanse skin with DiaSinc All Purpose Cleansing Spray and apply paste to area as needed.
- Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
- Other information
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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™
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INGREDIENTS AND APPEARANCE
ZINCTRAL
zinc oxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59088-627 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-627-05 57 g in 1 TUBE; Type 0: Not a Combination Product 03/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/24/2023 Labeler - PureTek Corporation (785961046)
