Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID aa9ae4d1-4229-4894-9eaf-8588b2867472
Route
TOPICAL
Published
Effective Date 2023-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.2 g)
Inactive Ingredients
Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Light Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-04
Description

Zinc Oxide 20%

Medication Information

Warnings and Precautions

For external use only.

When using this product  Do not get into eyes

Stop use and ask a doctor if

  • condition worsens 
  • symptoms last more than 7 days or clear up and occur again within a few days  
Indications and Usage
  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • Dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Dosage and Administration

For Diaper Rash:

  • Change wet and soild diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For Poison Ivy, oak and sumac:

  • Apply as needed

Description

Zinc Oxide 20%

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, White Petrolatum

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

Zinc Oxide 20%

Structured Label Content

Indications and Usage (34067-9)
  • Helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
  • Dries the oozing and weeping of poison ivy, poison oak, and poison sumac
Dosage and Administration (34068-7)

For Diaper Rash:

  • Change wet and soild diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For Poison Ivy, oak and sumac:

  • Apply as needed

Warnings and Precautions (34071-1)

For external use only.

When using this product  Do not get into eyes

Stop use and ask a doctor if

  • condition worsens 
  • symptoms last more than 7 days or clear up and occur again within a few days  
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Ceteareth 20, Cetostearyl Alcohol, Light Mineral Oil, White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

Zinc Oxide 20%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:25.037088 · Updated: 2026-03-14T23:10:48.259693