SPL v1
SPL
SPL Set ID 0ba98cdf-489e-dc2a-e063-6294a90adb38
Route
TOPICAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.4 g)
Inactive Ingredients
Lanolin Mineral Oil Isopropyl Myristate Cod Liver Oil Aloe Vera Leaf .alpha.-tocopherol Acetate Petrolatum Yellow Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-04
Description

Zinc Oxide 40%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Zinc Oxide 40%

Use
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4

Warnings

For external use only

Directions
  • change wet and soilded diapers promtly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged.
Active Ingredient

Zinc Oxide 40%

Other Information
  • store at 68º-77ºF(20º to 25ºC)
  • do not use if tube seal under cap is broken or missing
Inactive Ingredients

Petrolatum

Mineral Oil

Lanolin

Isopropyl Myristate

Beeswax

Tocopheryl Acetate

Cod Liver Oil

Aloe Barbadensis Leaf Juice

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 worsen
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

Structured Label Content

Use
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions
  • change wet and soilded diapers promtly
  • cleanse the diaper area
  • allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers will be prolonged.
Active Ingredient (Active ingredient)

Zinc Oxide 40%

Other Information (Other information)
  • store at 68º-77ºF(20º to 25ºC)
  • do not use if tube seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

Petrolatum

Mineral Oil

Lanolin

Isopropyl Myristate

Beeswax

Tocopheryl Acetate

Cod Liver Oil

Aloe Barbadensis Leaf Juice

When Using This Product (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)

Stop use and ask a doctor if

  • condition worsen
  • symptoms last more than 7 days or clear up and occur again within a few 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: 2026-02-15T12:02:26.793503 · Updated: 2026-03-14T23:01:59.101977