FDA.reportPublic FDA data

DEBACHERE Butt Balm After Care Antiseptic Pain Relief

Manufacturer
DE.BACHERE USA LLC
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:31:46

Label at a glance#

ProductDEBACHERE Butt Balm After Care Antiseptic Pain Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. First aid help prevent infection in minor cuts, scrapes, and burns.

Dosage and administration

Clean the affected area. Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5.00%

Benzalkonium Chloride 0.10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Antiseptic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
  • First aid help prevent infection in minor cuts, scrapes, and burns.

Warnings:

WARNINGS SECTION

For external use only,not intended for ingestion.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area.
  • Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

Store at 20-25°C (60-77°F) and protect from moisture.

Inactive Ingridients:

INACTIVE INGREDIENT SECTION

Aloe extract, Beeswax, Camphor, Cetyl Esters, Ethyl vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Salicylic Acid, Theobroma Cacao (cocoa) butter, FD&C Blue # 1.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84847-540-00DEBACHERE Butt Balm After Care Antiseptic Pain Relief3 mL in 1 PACKETCREAM31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84847-540DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF (BENZOCAINE, BENZALKONIUM CHLORIDE) CREAM [DE.BACHERE USA LLC]1Current NDC, 1 package rows20241031_8ba42864-69bf-455c-98d4-7f4ff94edceb.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84847-54084847-540-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
YELLOW WAX2ZA36H0S2VIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CETYL ESTERS WAXD072FFP9GUIACT
ETHYL VANILLINYC9ST449YJIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LANOLIN7EV65EAW6HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PARAFFINI9O0E3H2ZEIACT
SALICYLIC ACIDO414PZ4LPZIACT
COCOAD9108TZ9KGIACT
BENZOCAINEU3RSY48JW5ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
DEBACHERE Butt Balm After Care Antiseptic Pain ReliefBENZOCAINE, BENZALKONIUM CHLORIDEDE.BACHERE USA LLC8ba42864-69bf-455c-98d4-7f4ff94edceb2024-10-29WarningsExact identifier
ndc (package): 84847-540-00
ndc (product): 84847-540
ndc11 (package): 84847054000
spl id: 259f4642-0f3c-907c-e063-6294a90a3491
spl set id: 8ba42864-69bf-455c-98d4-7f4ff94edceb

Reported adverse events (FAERS/openFDA)#

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