Swan_simply U 020.002/020ad

SPL v3

SPL

SPL Set ID 66771beb-9c14-48a8-a850-000e4cd73a90

Route

TOPICAL

Published

Effective Date 2025-03-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (400 mg)

Inactive Ingredients

Petrolatum Cod Liver Oil Lanolin Starch, Corn Glycerin Sorbitan Sesquioleate Yellow Wax .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Zinc oxide 40%

Purpose

Skin protectant

Adverse Reactions

Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 Dermatologist Tested Pediatrician Tested Hypoallergenic

Medication Information

Purpose

Skin protectant

Adverse Reactions

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114 1-888-593-0593

Dermatologist Tested

Pediatrician Tested

Hypoallergenic

Description

Zinc oxide 40%

Uses

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

Warnings

For external use only

Directions

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

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor fo Desitin ^®Maximum Strength 40% Zinc Oxide Diaper Rash Paste.

Active Ingredient

Zinc oxide 40%

Other Information

store between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive Ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Principal Display Panel

Swan baby

Compare to Desitin ^®Maximum Strength Diaper Rash Paste*

maximum strength

diaper rash ointment

skin protectant/40% zinc oxide

helps heal, soothe, & prevent diaper rash
paraben, phthalate and quaternium-15 free
pediatrician and dermatologist tested

NET WT 4 OZ (113 g)

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 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

Uses

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 ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Disclaimer

*This product is not manufactured or distributed by Kenvue, Inc., distributor fo Desitin ^®Maximum Strength 40% Zinc Oxide Diaper Rash Paste.

Active Ingredient (Active ingredient)

Zinc oxide 40%

Adverse Reactions (Adverse reactions)

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114 1-888-593-0593

Dermatologist Tested

Pediatrician Tested

Hypoallergenic

Other Information (Other information)

store between 20⁰ and 25⁰C (68⁰ and 77⁰F)

Inactive Ingredients (Inactive ingredients)

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance

Principal Display Panel (Principal display panel)

Swan baby

Compare to Desitin ^®Maximum Strength Diaper Rash Paste*

maximum strength

diaper rash ointment

skin protectant/40% zinc oxide

helps heal, soothe, & prevent diaper rash
paraben, phthalate and quaternium-15 free
pediatrician and dermatologist tested

NET WT 4 OZ (113 g)

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 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

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Raw Label Data

All Sections (JSON)

{"Uses": "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 ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged", "Disclaimer": "*This product is not manufactured or distributed by Kenvue, Inc., distributor fo Desitin ® Maximum Strength 40% Zinc Oxide Diaper Rash Paste.", "Active ingredient": "Zinc oxide 40%", "Adverse reactions": "Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593 Dermatologist Tested Pediatrician Tested Hypoallergenic", "Other information": "store between 20⁰ and 25⁰C (68⁰ and 77⁰F)", "Inactive ingredients": "petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocopheryl acetate, fragrance", "Principal display panel": "Swan baby Compare to Desitin ® Maximum Strength Diaper Rash Paste* maximum strength diaper rash ointment skin protectant/40% zinc oxide helps heal, soothe, & prevent diaper rash paraben, phthalate and quaternium-15 free pediatrician and dermatologist tested NET WT 4 OZ (113 g)", "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 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: 2026-02-15T12:05:46.911635 · Updated: 2026-03-14T23:08:04.646392