Diaper Rash Cream 15oz

SPL v1

SPL

SPL Set ID 213213ab-f935-a62e-e063-6394a90af96b

Route

TOPICAL

Published

Effective Date 2024-09-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (40 g)

Inactive Ingredients

Aloe Vera Leaf .alpha.-tocopherol Acetate Isopropyl Myristate Cod Liver Oil Mineral Oil Yellow Wax Petrolatum Lanolin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-03

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

Label

Warnings

For external use only

Directions

change wet and soiled diapers promptly
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 prlonged

Active Ingredient

Zinc Oxide(40%)

Other Information

store at 68° to 77° F (20° to 25°C)
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

condition worsens
symptoms last more than 7 days or clear up and occur again with 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

Label (label)

Purpose

Skin Protectant

Warnings

For external use only

Directions

change wet and soiled diapers promptly
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 prlonged

Active Ingredient (Active ingredient)

Zinc Oxide(40%)

Other Information (Other information)

store at 68° to 77° F (20° to 25°C)
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)

condition worsens
symptoms last more than 7 days or clear up and occur again with 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

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COD LIVER OIL", "unii": "BBL281NWFG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness", "Purpose": "Skin Protectant", "Warnings": "For external use only", "Directions": "change wet and soiled diapers promptly 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 prlonged", "Active ingredient": "Zinc Oxide(40%)", "Other information": "store at 68° to 77° F (20° to 25°C) 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": "condition worsens symptoms last more than 7 days or clear up and occur again with a few days.", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:31.649750 · Updated: 2026-03-14T23:03:38.391930