3e1f9d2e-c259-4c42-e054-00144ff88e88

SPL v1
SPL
SPL Set ID 3e1f9d2e-c259-4c42-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (3.8 g)
Inactive Ingredients
corn oil sodium borate alpha-tocopherol aloe vera leaf chloroxylenol cholecalciferol lanolin mineral oil paraffin phenoxyethanol vitamin a palmitate water petrolatum

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2016-10-06
Purpose

Skin Protectant

Description

Zinc Oxide 3.8%

Medication Information

Warnings

FOR EXTERNAL USE ONLY

Uses
  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects skin against irritation due to such rash
  • Helps protect skin from exposure to wetness
Purpose

Skin Protectant

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 any time when exposure to

soiled diapers may be prolonged

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

Description

Zinc Oxide 3.8%

Section 51945-4

Active Ingredient

Zinc Oxide 3.8%

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

Warnings

FOR EXTERNAL USE ONLY

Uses
  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects skin against irritation due to such rash
  • Helps protect skin from exposure to wetness
Purpose

Skin Protectant

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 any time when exposure to

soiled diapers may be prolonged

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

Section 51945-4 (51945-4)

Active Ingredient

Zinc Oxide 3.8%

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: 2026-02-15T11:56:10.890282 · Updated: 2026-03-14T22:54:27.650645