Skylark Zinc Oxide 20% Diaper Rash Cream

Skylark Zinc Oxide 20% Diaper Rash Cream
SPL v1
SPL
SPL Set ID 58eec6dd-be0e-bafc-e053-2a91aa0a97cf
Route
TOPICAL
Published
Effective Date 2017-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Ceteth-20 Petrolatum Cetostearyl Alcohol Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-09-01
Description

Zinc Oxide (20% w/w)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide (20% w/w)

Warnings

For external use only

Directions
  • for diaper rash
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • for poison ivy, oak, sumac
  • apply ointment liberally as often as needed
Package Label

Active Ingredient

Zinc Oxide (20% w/w)

Other Information
  • store at 56°-86° F (15-30°C)
  • avoid excessive heat
Inactive Ingredients

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin

When Using This Product
  • do not get into eyes
  • do not use over large areas of the body
Stop Use and Ask A Doctor If
  • if condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • if you are allergic to any of these ingredients
Keep Out of Reach of Children
  • if swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • for diaper rash
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • for poison ivy, oak, sumac
  • apply ointment liberally as often as needed
Package Label (PACKAGE LABEL)

Active Ingredient (Active ingredient)

Zinc Oxide (20% w/w)

Other Information (Other information)
  • store at 56°-86° F (15-30°C)
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin

When Using This Product (When using this product)
  • do not get into eyes
  • do not use over large areas of the body
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • if condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • if you are allergic to any of these ingredients
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: 2026-02-15T11:56:24.840689 · Updated: 2026-03-14T22:54:51.534540