SPL v2
SPL
SPL Set ID 5b5fd17a-255f-c937-e053-2a91aa0a1391
Route
TOPICAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10 g)
Inactive Ingredients
.alpha.-tocopherol Propylene Glycol Cod Liver Oil Cetostearyl Alcohol Trolamine Mineral Oil Edetic Acid Stearic Acid Propylparaben Water Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-10-12
Description

Zinc Oxide 10%

Purpose

diaper rash cream

Medication Information

Purpose

diaper rash cream

Description

Zinc Oxide 10%

Uses
  • helps treat and prevent diaper rash
  • protects minor skin irritation due to diaper rash and helps seal out wetness
Section 44425-7

store between 20°C to 25 °C ( 68° to 77°F)

Section 50565-1



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

Section 51945-4

Maximum Strength

NET WEIGHT 0.7 oz (20g)

NDC#70648-444-01

Warning
  • For external use only
  • when using this product, do not get it into the eye
Questions

www.ohiolabpharma.us

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredients

Zinc Oxide 10%

Inactive Ingredients

cod liver oil ( contains vitamin A & Vitamin D), propylene glycol, vitamin E, methylparaben, propylparaben, stearic acid, trolamine, ceteareth 20, cetostearyl alcohol, EDTA, mineral oil

Stop Using This Product and Ask A Doctor
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects minor skin irritation due to diaper rash and helps seal out wetness
Section 44425-7 (44425-7)

store between 20°C to 25 °C ( 68° to 77°F)

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 51945-4 (51945-4)

Maximum Strength

NET WEIGHT 0.7 oz (20g)

NDC#70648-444-01

Warning
  • For external use only
  • when using this product, do not get it into the eye
Purpose (purpose)

diaper rash cream

Questions (questions)

www.ohiolabpharma.us

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredients

Zinc Oxide 10%

Inactive Ingredients

cod liver oil ( contains vitamin A & Vitamin D), propylene glycol, vitamin E, methylparaben, propylparaben, stearic acid, trolamine, ceteareth 20, cetostearyl alcohol, EDTA, mineral oil

Stop Using This Product and Ask A Doctor (Stop using this product and ask a doctor)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.016472 · Updated: 2026-03-14T22:55:19.604592