FDA.reportPublic FDA data

SANAR - ARNICA ROLL ON

Manufacturer
SANVALL ENTERPRISES, INC
Effective date
2023-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:32:29

Label at a glance#

ProductSANAR - ARNICA ROLL ON
Active ingredientCAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

Aid for temporary local relief of minor pain in muscles or joints.

Dosage and administration

Adults and Children over 12 years: Apply generously to affected area. Massage until thoroughly absorbed.Repeat as necessary, but not more than 3 times daily. Children under 12 years: Consult a doctor.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 1%

OTC - PURPOSE SECTION

Pain Relieving

Uses:

INDICATIONS & USAGE SECTION

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - DO NOT USE SECTION

Use on wounds or damaged skin • bandage tightly.

Stop use and consult a doctor if

OTC - STOP USE SECTION

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 12 years: Apply generously to affected area. Massage until thoroughly absorbed.Repeat as necessary, but not more than 3 times daily. Children under 12 years: Consult a doctor.

OTHER SAFETY INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-77° F (15°-25° C). • Processed under the highest standards of quality assurance and Good Manufacturing Practices

INACTIVE INGREDIENT SECTION

Aqua, Ceteareth-25, Arnica Montana Flower Extract, Alcohol Denat, Menthol, Glycerin, Triethanolamine, Methyl Salicylate, Carbomer, Eucalyptus Globulus Leaf Oil, Disodium EDTA, Tocopheryl Acetate, Capsicum Annuum Fruit Extract, Methylchloroisothiazolinone, Methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3oz3oz

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73386-00573386-005-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSICUM00UK7646FGIACT
ALCOHOL3K9958V90MIACT
METHYL SALICYLATELAV5U5022YIACT
CARBOMER 9404Q93RCW27EIACT
MENTHOLL7T10EIP3AIACT
GLYCERINPDC6A3C0OXIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
WATER059QF0KO0RIACT
CETEARETH-258FA93U5T67IACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
276d878a-c735-8257-e063-6394a90a8678ccfec720-52bb-b5c6-e053-2a95a90aaeae2024-11-21WarningsExact identifier
spl set id: ccfec720-52bb-b5c6-e053-2a95a90aaeae

Reported adverse events (FAERS/openFDA)#

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