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Zinctral
zinc oxide · Zinctral is an over-the-counter drug containing zinc oxide, made by PureTek Corporation.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash.
Drug facts
- Generic name
- zinc oxide
- Active ingredients
- Zinc Oxide
- Dosage forms
- Paste
- Label holder
- PureTek Corporation
- FDA application
- M016
- Label updated
- 04/15/2024
Active ingredients
Zinc Oxide 20.0% (3.0% as Calamine) Purpose Skin Protectant
Purpose
Skin Protectant
Uses
Dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash. Protects minor skin irritations due to diaper rash and helps protect from wetness.
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.
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.
When using this product
Do not get into eyes
Stop use and ask a doctor
Condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Keep out of reach of children
Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center right away.
Other information
Protect from freezing avoid excessive heat Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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.
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Paste | 20 g/100g | topical | 1 |
Manufacturers and labels
1 FDA label
- PureTek CorporationShown hereM016 · Label 04/15/2024 · NDC 59088-627Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing12/10/2025Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw...Blossom Pharmaceuticals · 7 products · cGMP deviations
- Class IIDrugOngoing12/03/2025Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA...CA BOTANA International, Inc. · 8 products · CGMP Deviations
- Class IIDrugOngoing11/26/2025Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777...DermaRite Industries, LLC · CGMP Deviation; manufactured at the same facility where other...
- Class IIDrugOngoing09/17/2025Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl....GRACE & FIRE PTY LTD · 2 products · Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen...
- Class IIDrugOngoing07/16/2025B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint...KABANA SKIN CARE · 4 products · cGMP deviations
Zinctral: common questions
- What is Zinctral used for?
- dries the oozing and weeping of poison: ivy oak sumac Helps treat and prevent diaper rash.
- Is Zinctral a prescription drug?
- No. Zinctral is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Zinctral?
- Yes. Other FDA-listed products with the same active ingredients include Diaper Rash, Zinc Oxide 20%, SPF 50 Sunscreen Stick, Cream.
- Who makes Zinctral?
- PureTek Corporation lists Zinctral with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 04/15/2024 · Label text is shown as published by the manufacturer. Not medical advice