FDA.reportPublic FDA data

Soothing Incontinence Spray

Manufacturer
Beyond Health P.A. | Derma Care Research Labs
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:46

Label at a glance#

ProductDr. Butler Soothing Incontinence
Active ingredientMINERAL OIL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 36%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve chafed, chapped, or cracked skin.

WARNINGS SECTION

For external use only.

Do not use on deep or puncture wounds.

When using this product avoid contact in eyes, rinse with water to remove, contents under pressure, do not puncture or incinerate, do not store at temperatures above 120F.

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 - PREGNANCY OR BREAST FEEDING SECTION

Ask a healthcare or professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Shake well. Hold 4-6 inches from the skin and apply a thin continuous coating. Apply as needed.

INACTIVE INGREDIENT SECTION

4-t-Butylcyclohexanol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Helianthus Annuus (Sunflower) Seed Oil, Mineral Oil, Pentylene Glycol, PPG-15 Stearyl Ether.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-017-03Dr. Butler Soothing Incontinence85 g in 1 CANSPRAY853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-017DR. BUTLER SOOTHING INCONTINENCE (PETROLATUM 36%) SPRAY [BEYOND HEALTH P.A.]3Current NDC, Legacy NDC, 1 package rows20241217_d17a0c28-a5b7-4df0-e053-2995a90a8edd.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70942-01770942-017-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PPG-15 STEARYL ETHER1II18XLS1LIACT
ALOEV5VD430YW9IACT
4-TERT-BUTYLCYCLOHEXANOLK0H1405S9CIACT
PENTYLENE GLYCOL50C1307PZGIACT
CHAMOMILEFGL3685T2XIACT
SUNFLOWER OIL3W1JG795YIIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UIACT

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
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
ndc (package): 70942-017-03
ndc (product): 70942-017
ndc11 (package): 70942001703
spl id: 2958cebe-650d-ea65-e063-6394a90a3f39
spl set id: d17a0c28-a5b7-4df0-e053-2995a90a8edd

Reported adverse events (FAERS/openFDA)#

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