Soothing Bath Treatment

Manufacturer
Cardinal Health
Effective date
2009-12-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:31

Label at a glance#

ProductSoothing Bath Treatment
Active ingredientOATMEAL
Label structure6 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal, 100%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USE

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION


OTC - ASK DOCTOR SECTION


OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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 LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-178-51

LEADER                          SATISFACTION GUARANTEED

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

*Compare to active ingredient of Aveeno®

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 Cardinal Health
Dublin, OH 43017
CIN 2434504
www.myleader.com
MADE IN USA

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

image of carton
image of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-178-512025-04-23C16284748780-1956f9ecf-c7e3-621f-e053-dbdaa90a74adDRUG FACTS
37205-178-512019-10-21C16284748780-1956f9ecf-c7e3-621f-e053-dbdaa90a74adDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-178-51EA - Each37205-178ab10d1b9-d59c-4150-80f9-b64a3b1ca39312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OATMEALACTIVE INGREDIENT8PI54V663Y1
OATMEALACTIVE MOIETY8PI54V663Y1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-17837205-178-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f8e50a3c-ff76-4548-9b2f-799b38286ad9a9742bef-3749-4d3f-b479-1ac88fce9a962025-04-17WarningsExact identifier
spl set id: a9742bef-3749-4d3f-b479-1ac88fce9a96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.