SPL v1
SPL
SPL Set ID 58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14
Route
TOPICAL
Published
Effective Date 2017-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-08-01
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
Section 51945-4

Warnings

FOR EXTERNAL USE ONLY

Directions
  • Change wet or 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
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, Tocopherol 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 rightaway

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
Section 51945-4 (51945-4)

Purpose

Skin Protectant

Warnings

FOR EXTERNAL USE ONLY

Directions
  • Change wet or 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
Active Ingredient (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, Tocopherol 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 rightaway

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:24.824206 · Updated: 2026-03-14T22:54:51.534540