FDA.reportPublic FDA data

Bodewell Eczema Daily Calming Cream

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-11-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:20:36

Label at a glance#

ProductBodewell Eczema Daily Calming
Active ingredientOATMEAL
Label structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, rashes, poison ivy, oak or sumac, insect bites

Warnings

WARNINGS SECTION

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - WHEN USING SECTION

Do not get into eyes.

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

INACTIVE INGREDIENT SECTION

Water, dimethicone, glycerin, stearic acid, cetyl alcohol, cocos nucifera (coconut) oil, glyceryl stearate, niacinamide, sodium PCA, phenoxyethanol, petrolatum, triethanolamine, carbomer, caprylyl glycol, tocopheryl acetate, alcohol, hamamelis virginiana (witch hazel) bark/leaf extract, avena sativa (oat) seed extract, populus alba bark extract, populus tremuloides bark extract, cochlearia officinalis flower/leaf/stalk extract, phytolacca decandra root extract, lens esculenta (lentil) fruit extract, berberis vulgaris bark extract, scrophularia nodosa extract, veronica officinalis extract, sanguinaria canadensis rhizome/root extract, althaea officinalis root extract, chamomilla recutita (matricaria) flower extract, sambucus nigra extract, achillea millefolium extract, aesculus hippocastanum (horse chestnut) seed extract, malva sylvestris (mallow) leaf extract, nasturtium officinale leaf extract, smilax medica root extract, tussilago farfara (coltsfoot) leaf extract, pimpinella saxifraga extract, vincetoxicum hirundinaria root extract

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-213-1873

SPL UNCLASSIFIED SECTION

Dist. by The Procter & Gamble Distributing, LLC

Cincinnati, OH 45202

MADE IN USA of U.S. and/or Importing Ingredients

bodewellskin.com

PRINCIPAL DISPLAY PANEL - 237 mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bodewell

eczema daily

calming cream

Colloidal Oatmeal

Skin Protectant

8.0 FL OZ (237 mL)

BodewellBodewell

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-61469423-614-23, 69423-614-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
LENS CULINARIS FRUITZYZ076G9JHIACT
ALTHAEA OFFICINALIS ROOTTRW2FUF47HIACT
PIMPINELLA SAXIFRAGA WHOLELCL1491142IACT
SMILAX ARISTOLOCHIAEFOLIA ROOTNR100Y25G0IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TUSSILAGO FARFARA LEAFG2GH7V846ZIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHAMOMILEFGL3685T2XIACT
COCHLEARIA OFFICINALIS FLOWERING TOPM87UN67CKRIACT
NASTURTIUM OFFICINALE LEAF362629QKRTIACT
NIACINAMIDE25X51I8RD4IACT
PETROLATUM4T6H12BN9UIACT
PHYTOLACCA AMERICANA ROOT11E6VI8VEGIACT
POPULUS ALBA BARKK12723D3GVIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OATMEAL8PI54V663YACTIB
STEARIC ACID4ELV7Z65APIACT
VERONICA OFFICINALIS WHOLE9EHR580PSPIACT
SAMBUCUS NIGRA WHOLE4X6JT95SYNIACT
SANGUINARIA CANADENSIS ROOTN9288CD508IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
TROLAMINE9O3K93S3TKIACT
VINCETOXICUM HIRUNDINARIA ROOT9R858U917WIACT
COCONUT OILQ9L0O73W7LIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
SCROPHULARIA NODOSA7H443NUB2TIACT
HORSE CHESTNUT3C18L6RJAZIACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UIACT
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKIACT
ALCOHOL3K9958V90MIACT
MALVA SYLVESTRIS LEAF17H39B00T5IACT
POPULUS TREMULOIDES BARK5543O0CEIDIACT

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
0a32f947-7ac6-c4ba-e063-6394a90afe23d91ce552-9bfc-2fdb-e053-2a95a90ae2772023-11-15WarningsExact identifier
spl id: 0a32f947-7ac6-c4ba-e063-6394a90afe23
spl set id: d91ce552-9bfc-2fdb-e053-2a95a90ae277

Reported adverse events (FAERS/openFDA)#

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