FDA.reportPublic FDA data

Belladona & Árnica Analgesic Ointment

Manufacturer
Dannso Corp./d.b.a. Essential Products | Miramar Cosmetic Inc.
Effective date
2026-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:27

Label at a glance#

ProductBelladona and Arnica
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

For the temporary relief of minor pains associated with muscles and joints, backache, arthritis, strains, sprains and cramps.

Dosage and administration

Adults and children 12 years of age or older: apply generously to affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - Active Ingredient Section

Active ingredientStrengthPurpose
Menthol4%External Analgesic

Purpose

OTC - Purpose Section

External Analgesic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children to avoid accidental poisoning.

Indications and usage

INDICATIONS & USAGE SECTION

For the temporary relief of minor pains associated with muscles and joints, backache, arthritis, strains, sprains and cramps.

Warnings

WARNINGS SECTION

For external use only

Use only as directed.

Do not use:

  • on wounds or damaged skin
  • with a heating pad
  • on children under 12 years of age
  • on irritated skin
  • with a bandage
  • on eyes or mucous membranes

Ask a doctor before use if redness is present on the affected area.

Stop use and ask a doctor if:

  • excessive irritation develops
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age or older: apply generously to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Belladona extract
  • Arnica
  • Paraffin wax
  • DC Green #6
  • DC Yellow #1
  • Snow white petrolatum

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Belladona & Arnica Analgesic Ointment LabelBelladona & Arnica Analgesic Ointment Label

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70242-13370242-133-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
BELLADONNA LEAF6GZW20TIOIIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
PARAFFINI9O0E3H2ZEIACT
D&C GREEN NO. 64QP5U84YF7IACT
D&C YELLOW NO. 1144F3HYL954IACT
D&C RED NO. 17ND733RX3JNIACT
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
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
ndc (package): 70242-133-05
ndc (product): 70242-133
ndc11 (package): 70242013305
spl id: 24945e94-4a9e-4b95-8dc6-ae70e050d7fa
spl set id: fc4e63e4-cebc-49ff-8900-7238261d0fe0

Reported adverse events (FAERS/openFDA)#

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