Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7b20dedd-a991-486f-e053-2991aa0ab6ea
Route
TOPICAL
Published
Effective Date 2015-01-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3.8 g)
Inactive Ingredients
Aloe Vera Leaf Chloroxylenol Cholecalciferol Corn Oil Lanolin Mineral Oil Paraffin Phenoxyethanol Vitamin A Palmitate Sodium Borate Alpha-tocopherol Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-01-01
Description

Zinc Oxide 3.8%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 3.8%

Uses

■ Helps treat and prevent diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash an ■ 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 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, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopheryl Acetate (Vitamin E) Water, White Petrolatum

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 diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash an ■ 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 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, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopheryl Acetate (Vitamin E) Water, White Petrolatum

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:40.985238 · Updated: 2026-03-14T22:55:19.604592