Diaper Rash Cream 2.5oz

SPL v3

SPL

SPL Set ID 130d94d8-ad98-d61f-e063-6294a90a76b0

Route

TOPICAL

Published

Effective Date 2024-03-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (40 g)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-07

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

Warnings: For external use only.

Directions

change wet and soiled diapers promotly
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 prolonged

Do Not Use

Do not use if tube seal under cap is broken or missing

Active Ingredient

Zinc Oxide 40%

Other Information

store at 68º to 77ºF (20º to 25ºC)
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
symtoms last more than 7 days or clear up and occur again within 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

Warnings: For external use only.

Directions

change wet and soiled diapers promotly
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 prolonged

Do Not Use (Do not use)

Do not use if tube seal under cap is broken or missing

Active Ingredient (Active ingredient)

Zinc Oxide 40%

Other Information (Other information)

store at 68º to 77ºF (20º to 25ºC)
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
symtoms last more than 7 days or clear up and occur again within 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": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "COD LIVER OIL", "unii": "BBL281NWFG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "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": "Warnings: For external use only.", "Directions": "change wet and soiled diapers promotly 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 prolonged", "Do not use": "Do not use if tube seal under cap is broken or missing", "Active ingredient": "Zinc Oxide 40%", "Other information": "store at 68º to 77ºF (20º to 25ºC) 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 symtoms last more than 7 days or clear up and occur again within 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: 2026-02-15T12:03:55.233998 · Updated: 2026-03-14T23:04:16.644897