Aveeno Baby ®

SPL v10

SPL

SPL Set ID e7eb10b7-3950-49cb-ba73-11e7581b6be9

Route

TOPICAL

Published

Effective Date 2021-05-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Oatmeal (430 mg)

Inactive Ingredients

Mineral Oil Calcium Silicate Laureth-4

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2012-01-01 Until 2025-05-01

Description

Drug Facts

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

Rashes
Eczema
Poison ivy, oak or sumac
Insect bites

Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

For external use only.

Directions

For dispersal in water:

Turn warm water faucet on to full force.
Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container.
Stir any colloidal oatmeal settled on the bottom.

For use as a soak in a bath:

Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom.
Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor.
Pat dry (do not rub) to keep a thin layer on the skin.

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Active Ingredient

Colloidal oatmeal 43%

Other Information

Store at room temperature.

Inactive Ingredients

mineral oil, calcium silicate, laureth-4

When Using This Product

Do not get into eyes.
To avoid slipping, use mat in tub or shower.
In some skin conditions, soaking too long may overdry.

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.

Principal Display Panel 106 G Packet Carton

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno _®

baby

eczema

therapy

soothing bath treatment

colloidal oatmeal

skin protectant

relieves dry, itchy,

irritated skin due to:

eczema, rashes,

poison ivy/oak/sumac,

insect bites

fragrance-free, allergy-tested

steroid-free

ACCEPTED

NATIONALECZEMA.ORG

NATIONAL

ECZEMA

ASSOCIATION

5 Bath Packets

TOTAL NET WT. 3.75 OZ (106 g)

Structured Label Content

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to:

Rashes
Eczema
Poison ivy, oak or sumac
Insect bites

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Skin protectant

Warnings

For external use only.

Directions

For dispersal in water:

Turn warm water faucet on to full force.
Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container.
Stir any colloidal oatmeal settled on the bottom.

For use as a soak in a bath:

Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom.
Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor.
Pat dry (do not rub) to keep a thin layer on the skin.

Questions?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Active Ingredient (Active ingredient)

Colloidal oatmeal 43%

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

mineral oil, calcium silicate, laureth-4

When Using This Product (When using this product)

Do not get into eyes.
To avoid slipping, use mat in tub or shower.
In some skin conditions, soaking too long may overdry.

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.

Principal Display Panel 106 G Packet Carton (PRINCIPAL DISPLAY PANEL - 106 g Packet Carton)

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno _®

baby

eczema

therapy

soothing bath treatment

colloidal oatmeal

skin protectant

relieves dry, itchy,

irritated skin due to:

eczema, rashes,

poison ivy/oak/sumac,

insect bites

fragrance-free, allergy-tested

steroid-free

ACCEPTED

NATIONALECZEMA.ORG

NATIONAL

ECZEMA

ASSOCIATION

5 Bath Packets

TOTAL NET WT. 3.75 OZ (106 g)

Advanced Ingredient Data

[{"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM SILICATE", "unii": "S4255P4G5M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURETH-4", "unii": "6HQ855798J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OATMEAL", "unii": "8PI54V663Y", "classCode": "ACTIB", "strengthNumerator": "430", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily protects and helps relieve minor skin irritation and itching due to: Rashes Eczema Poison ivy, oak or sumac Insect bites", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away.", "Purpose": "Skin protectant", "Warnings": "For external use only.", "Directions": "For dispersal in water: Turn warm water faucet on to full force. Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal settled on the bottom. For use as a soak in a bath: Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom. Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor. Pat dry (do not rub) to keep a thin layer on the skin.", "Questions?": "866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com", "Active ingredient": "Colloidal oatmeal 43%", "Other information": "Store at room temperature.", "Inactive ingredients": "mineral oil, calcium silicate, laureth-4", "When using this product": "Do not get into eyes. To avoid slipping, use mat in tub or shower. In some skin conditions, soaking too long may overdry.", "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.", "PRINCIPAL DISPLAY PANEL - 106 g Packet Carton": "RECOMMENDED BY PEDIATRICIANS & DERMATOLOGISTS Aveeno ® baby eczema therapy soothing bath treatment colloidal oatmeal skin protectant relieves dry, itchy, irritated skin due to: eczema, rashes, poison ivy/oak/sumac, insect bites fragrance-free, allergy-tested steroid-free ACCEPTED e NATIONALECZEMA.ORG NATIONAL ECZEMA ASSOCIATION 5 Bath Packets TOTAL NET WT. 3.75 OZ (106 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:38.757830 · Updated: 2026-03-14T23:09:31.593516