Zinctral

Zinctral
SPL v2
SPL
SPL Set ID de990834-00da-0c7a-e053-2995a90a7c37
Route
TOPICAL
Published
Effective Date 2019-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Starch, Corn Aluminum Starch Octenylsuccinate Levomenol Kukui Nut Oil Aloe Vera Leaf Calcium Pantothenate Carthamus Tinctorius (safflower) Oleosomes Maltodextrin Niacinamide Petrolatum Phenoxyethanol Pyridoxine Hydrochloride Silicon Dioxide Sodium Ascorbyl Phosphate Hyaluronate Sodium Ginger .alpha.-tocopherol Acetate, Dl- Safflower Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-24

Description

Zinc Oxide 20.0% (3.0% as Calamine)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20.0% (3.0% as Calamine)

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.
Warnings

For external use only

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.
Zinctral™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information call toll-free: 877-921-7873

Active Ingredient

Zinc Oxide 20.0%

(3.0% as Calamine)

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.

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.


Structured Label Content

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.
Purpose

Skin Protectant

Warnings

For external use only

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.
Zinctral™

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information call toll-free: 877-921-7873

Active Ingredient (Active ingredient)

Zinc Oxide 20.0%

(3.0% as Calamine)

Other Information (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: (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.

When Using This Product  (When using this product )
  • do not get into eyes
Stop Use and Ask A Doctor If (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. (Keep out of reach of childern.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)