Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 88d39029-f3e5-4be6-b456-98217818313f

Route

TOPICAL

Published

Effective Date 2010-03-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Oatmeal (1 g)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2003-07-17

Description

Colloidal Oatmeal, 100%

Purpose

Skin Protectant

Medication Information

Warnings and Precautions

Purpose

Skin Protectant

Description

Colloidal Oatmeal, 100%

Use

temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following:

rashes
eczema
poison ivy, oak, or sumac
insect bites

Section 42229-5

Section 44425-7

Section 50568-5

Section 50569-3

Section 50570-1

Section 51727-6

Section 53413-1

Section 53414-9

Warnings

For external use only.

Directions

Turn warm water faucet on to full force.
Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container.
Stir any colloidal oatmeal that may have settled to the bottom.
Soak affected area for 15-30 minutes as needed or as directed by a doctor.
Pat dry (do not rub) to keep a thin layer on the skin.

Package Information

NDC 49614-191-51

The Medicine Shoppe®

*Compare to active ingredient of Aveeno®

Soothing

Bath Treatment

Regular Formulation

100% Natural Colloidal Oatmeal

Skin Protectant

For fast temporary relief of itching , sore and sensitive skin due to:

Poison Ivy, Poison Sumac, Poison Oak, Insect Bites, Rashes and Eczema

TOTAL NET WEIGHT 12 oz (340 g)

8 INDIVIDUAL USE BATH PACKETS

1.5 oz. (42.5 g) EACH

*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.

Distributed by Medicine Shoppe International, Inc.

St. Louis, MO 63132

www.medicineshoppe.com

A Cardinal Health Company

CIN# 3449774

When Using This Product

do not get into eyes
in some skin conditions, soaking too long may overdry
to avoid slipping, use mat in tub or shower

Stop Use and Ask 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.

Active Ingredient (in Each Packet)

Colloidal Oatmeal, 100%

Structured Label Content

Use (USE)

temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following:

rashes
eczema
poison ivy, oak, or sumac
insect bites

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

Section 44425-7 (44425-7)

Section 50568-5 (50568-5)

Section 50569-3 (50569-3)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 53413-1 (53413-1)

Section 53414-9 (53414-9)

Purpose (PURPOSE)

Skin Protectant

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)

Turn warm water faucet on to full force.
Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container.
Stir any colloidal oatmeal that may have settled to the bottom.
Soak affected area for 15-30 minutes as needed or as directed by a doctor.
Pat dry (do not rub) to keep a thin layer on the skin.

Package Information (PACKAGE INFORMATION)

When Using This Product (When using this product)

do not get into eyes
in some skin conditions, soaking too long may overdry
to avoid slipping, use mat in tub or shower

Stop Use and Ask Doctor If (Stop use and ask 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.

Active Ingredient (in Each Packet) (ACTIVE INGREDIENT (in each packet))

Colloidal Oatmeal, 100%

Advanced Ingredient Data

[{"name": "OATMEAL", "unii": "8PI54V663Y", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USE": "temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following: rashes eczema poison ivy, oak, or sumac insect bites", "PURPOSE": "Skin Protectant", "WARNINGS": "For external use only.", "DIRECTIONS": "Turn warm water faucet on to full force. Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container. Stir any colloidal oatmeal that may have settled to the bottom. Soak affected area for 15-30 minutes as needed or as directed by a doctor. Pat dry (do not rub) to keep a thin layer on the skin.", "PACKAGE INFORMATION": "NDC 49614-191-51 The Medicine Shoppe® *Compare to active ingredient of Aveeno® Soothing Bath Treatment Regular Formulation 100% Natural Colloidal Oatmeal Skin Protectant For fast temporary relief of itching , sore and sensitive skin due to: Poison Ivy, Poison Sumac, Poison Oak, Insect Bites, Rashes and Eczema TOTAL NET WEIGHT 12 oz (340 g) 8 INDIVIDUAL USE BATH PACKETS 1.5 oz. (42.5 g) EACH *This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®. Distributed by Medicine Shoppe International, Inc. St. Louis, MO 63132 www.medicineshoppe.com A Cardinal Health Company CIN# 3449774", "When using this product": "do not get into eyes in some skin conditions, soaking too long may overdry to avoid slipping, use mat in tub or shower", "Stop use and ask 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.", "ACTIVE INGREDIENT (in each packet)": "Colloidal Oatmeal, 100%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:00.999346 · Updated: 2026-03-14T22:52:19.062647