FDA.reportPublic FDA data

Homeopathic Lip Balm

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:09:09

Label at a glance#

ProductHomeopathic Lip Balm
Active ingredientARNICA MONTANA
Label structure10 sections

Indications and uses

Temporarily relieves symptoms of pain and inflammation.

Dosage and administration

Apply to affected area 2 times daily or as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana (2X H.P.U.S.)

*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

Pain

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of pain and inflammation.

Warnings

WARNINGS SECTION

For external use only.

  • If swallowed, get medical help or contact a Poison Control Center Immediately.
  • Test for allergy by rubbing small amount on skin first.
  • Do not use if allergic to or hypersensitive to any ingredient.
  • If condition worsens or does not improve consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask a doctor if:

OTC - ASK DOCTOR SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • Irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area 2 times daily or as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Synthetic Beeswax, Isopropyl Palmitate, Menthol, Lanolin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Natural Flavor, Lavandula Angustifolia (Lavender) Oil, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Butyrospermum Parkii (Shea) Butter, Mentha Piperita (Peppermint) Leaf Oil, Isopropyl Myristate, Also Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) See Oil, Camphor, Butylene Glycol, Stevia Rebaudiana Leaf/Stem Extract.

Principal Display Panel, Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-111-012024-01-30C16284748780-11030e364-f8f3-111a-e063-dadaa90a10e2Real Time Pain Relief Homeopathic Lip Balm
58133-111-052024-01-30C16284748780-11030e364-f8f3-111a-e063-dadaa90a10e2Real Time Pain Relief Homeopathic Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-111-01Homeopathic Lip Balm5.5 g in 1 TUBEOINTMENT5.51
58133-111-05Homeopathic Lip Balm15 g in 1 JAROINTMENT151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-111HOMEOPATHIC LIP BALM (ARNICA MONTANA) OINTMENT [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20180110_62478131-4ed7-5407-e053-2991aa0a5aac.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-11158133-111-05, 58133-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR LEAF OIL51D0RGY52VIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
PETROLATUM4T6H12BN9UIACT
LAVANDULA ANGUSTIFOLIA WHOLE51217XIL5LIACT
BUTYROSPERMOL6SF0L0FL42IACT
MENTHA PIPERITA LEAFA389O33LX6IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
LANOLIN7EV65EAW6HIACT
ALOE VERA LEAFZY81Z83H0XIACT
SIMMONDSIA CHINENSIS LEAF67G221EK95IACT
COCOS NUCIFERA WHOLE245J88W96LIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ARNICA MONTANAO80TY208ZWACTIB
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT

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
62478131-4ed8-5407-e053-2991aa0a5aac62478131-4ed7-5407-e053-2991aa0a5aac2018-01-08WarningsExact identifier
spl id: 62478131-4ed8-5407-e053-2991aa0a5aac
spl set id: 62478131-4ed7-5407-e053-2991aa0a5aac

Reported adverse events (FAERS/openFDA)#

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