d6faa4d9-751c-a1b6-e053-2a95a90aee5b

SPL v8

SPL

SPL Set ID d6faa4d9-751c-a1b6-e053-2a95a90aee5b

Route

topical

Published

Effective Date 2022-02-01

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 stearic acid propylparaben water polyoxyl 20 cetostearyl ether cetostearyl alcohol trolamine mineral oil edetic acid

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2022-02-01

Purpose

diaper rash cream

Description

Zinc Oxide 10%

Medication Information

Uses

helps treat and prevent diaper rash
protects minor skin irritation due to diaper rash and helps seal out wetness

Purpose

diaper rash cream

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

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

Description

Zinc Oxide 10%

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

Warning

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

Questions

www.drspharmacyusa.com

Active Ingredients

Zinc Oxide 10%

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

Purpose (purpose)

diaper rash cream

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

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

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)

Warning

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

Questions (questions)

www.drspharmacyusa.com

Active Ingredients

Zinc Oxide 10%

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

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Raw Label Data

All Sections (JSON)

{"Uses": "helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness", "44425-7": "store between 20°C to 25 °C ( 68° to 77°F)", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Warning": "For external use only when using this product, do not get it into the eye", "purpose": "diaper rash cream", "questions": "www.drspharmacyusa.com", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.268596 · Updated: 2026-03-14T23:06:57.309434