Astonea Perishield

Astonea Perishield
SPL v2
SPL
SPL Set ID e5d284f3-839e-cd25-e053-2995a90ad479
Route
TOPICAL
Published
Effective Date 2020-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3.8 g)
Inactive Ingredients
Fd&c Yellow No. 5 Glyceryl Monostearate Aloe Vera Leaf Chloroxylenol Cholecalciferol Corn Oil Lanolin Phenoxyethanol Vitamin A Palmitate Sodium Borate Alpha-tocopherol Ethylhexylglycerin Sodium Laureth-3 Sulfate Stearic Acid Glycerin Cetostearyl Alcohol Microcrystalline Wax Isopropyl Myristate Mineral Oil Paraffin Water Food Yellow 3 Free Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-09

Description

Zinc Oxide 3.8%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 3.8%

Uses

■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ Helps protect skin from exposure to wetness

Warnings

For external use only

Directions

■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Package Label

Active Ingredient

Zinc Oxide 3.8%

Inactive Ingredients

Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

When Using This Product

■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

Stop Use and Ask A Doctor If

■ condition worsens or doesn't improve within seven days

Keep Out of Reach of Children

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


Structured Label Content

Uses

■ Helps treat and prevent rash associated with diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash and ■ Helps protect skin from exposure to wetness

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ Change wet and soiled diapers promptly ■ Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks,lower abdomen and inner thighs ■ Allow area to dry ■ Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Package Label

Active Ingredient

Zinc Oxide 3.8%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Gel, Alpha Tocopherol (Vitamin E), Cholecalciferol (Vitamin D), Chloroxylenol, Cetostearyl Alcohol, Corn Oil, Ethylhexylglycerin, FD&C Yellow No. 5, FD&C Yellow No. 6, Fragrance, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Microcrystalline wax, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Borate, Sodium Laureth-3 Sulfate, Stearic Acid, Vitamin A Palmitate, Water

When Using This Product (When using this product)

■ Avoid contact with eyes ■ If eye contact, occurs, flush with water

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

■ condition worsens or doesn't improve within seven days

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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