FDA.reportPublic FDA data

VIASOX - PAIN RELIEF GEL (ROLL ON) (82687-101)

Manufacturer
VIASOX LTD
Effective date
2022-05-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:01:35

Label at a glance#

ProductPAIN RELIEF ROLL ON
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT A PHYSICIAN.

Storage and handling

KEEP CAP TIGHTLY CLOSED. STORE IN A COOL, DRY PLACE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 11%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USE

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH SIMPLE BACKACHE, STRAINS, BRUISES, AND SPRAINS

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

DO NOT USE:

  • DO NOT USE AROUND EYE AREA, ON OPEN WOUNDS, CUTS, DAMAGED OR INFECTED SKIN, MOUTH, GENITALS OR ANY OTHER MUCOUS MEMBRANE
  • IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER
  • IF IRRITATION CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, DISCONTINUE USE OF THIS PRODUCT AND CONSULT A PHYSICIAN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT A PHYSICIAN.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE, GLYCERIN, BENZOIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDES, PHENOXYETHANOL, CETEARETH-6 OLIVATE, POTASSIUM CETYL PHOSPHATE, DENATURED DEHYDRATED ALCOHOL 40B, WATER, ETHYHEXYLGLYCERIN, XANTHAN GUM

OTHER INFORMATION:

STORAGE AND HANDLING SECTION

KEEP CAP TIGHTLY CLOSED. STORE IN A COOL, DRY PLACE.

QUESTIONS

OTC - QUESTIONS SECTION

IF YOU HAVE QUESTIONS OR CONCERNS PLEASE CALL+1 (855) 768-1227

WWW.VIASOX.COM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b_LBL_PainReliefGel_3oz01b_LBL_PainReliefGel_3oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82687-101-132024-03-28C16284748780-11030e364-fa58-111a-e063-dadaa90a10e2VIASOX - PAIN RELIEF GEL (ROLL ON) (82687-101)
82687-101-132024-01-30C16284748780-11030e364-fa58-111a-e063-dadaa90a10e2VIASOX - PAIN RELIEF GEL (ROLL ON) (82687-101)

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82687-10182687-101-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETEARETH-6 OLIVATE8834VWF9MOIACT
DEHYDRATED ALCOHOL3K9958V90MIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
14bc78f3-c974-d45f-e063-6294a90aa9e5dd949b29-e5ba-6e0d-e053-2995a90a60252024-03-28WarningsExact identifier
spl set id: dd949b29-e5ba-6e0d-e053-2995a90a6025

Reported adverse events (FAERS/openFDA)#

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