Dr. Butler Diaper Rash Cream

Manufacturer
Beyond Health P.A. | Derma Care Research Labs
Effective date
2023-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:34:04

Label at a glance#

ProductDr Butler Diaper Rash
Active ingredientDIMETHICONE 350
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash, protects minor skin irritation due to diaper rash and helps seal out wetness.

WARNINGS SECTION

For external use only.

Do not use on deep or puncture wounds, animal bites, or serious burns.

When using this product avoid contact with 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Water, glycerin, petrolatum, panthenol, stearyl alcohol, steareth-20, isopropyl palmitate, cetyl alcohol, avena sativa (oat) kernel oil, sodium hyaluronate, hamamelis virginiana (witch hzael) leaf extract, rosmarinus officinalis (rosemary) leaf extract, claendula officinalis flower extract, chamomilla recutita (matricaria) flower extract, curcuma longa (tumeric) root extract, olea europaea (olive) leaf extract, lavandula angustifolia (lavender) flower extract, helichrysum italicum extract, centella asiatica extract, panax ginseng root extract, aesculus hippocastanum (horse chestnut) extract, melaleuca alternifolia (tea tree) leaf extract, carya ovata bark extract, avena sativa (oat) kernel extract, cucumis sativus (cucumber) fruit extract, sorbitol, lecithin, xanthan gum, oleic acid, iron oxides (CI 77491), phenoxyethanol, ethylhexylglycerin, sodium chloride, colloidal oatmeal, 4-t-butylcyclohexanol, pentylene glycol, benzalkonium chloride, ceramide NP.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70942-259-032025-01-30C16284748780-12cef2736-9547-d83d-e063-dadaa90ab31fDr. Butler Diaper Rash Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-259DR BUTLER DIAPER RASH (DIMETHICONE 1%) CREAM [BEYOND HEALTH P.A.]1Unmatched20230324_f78143d5-4248-1f13-e053-6294a90acf85.zip

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
70942-25970942-259-03

Ingredients#

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

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

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
f78143d5-4249-1f13-e053-6294a90acf85f78143d5-4248-1f13-e053-6294a90acf852023-03-22WarningsExact identifier
spl id: f78143d5-4249-1f13-e053-6294a90acf85
spl set id: f78143d5-4248-1f13-e053-6294a90acf85

Reported adverse events (FAERS/openFDA)#

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