FDA.reportPublic FDA data

Flexall Pain Relieving

Manufacturer
Ari-Med Pharmaceuticals
Effective date
2020-10-27
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:09:45

Label at a glance#

ProductFlexall Pain Relieving
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 12 years: apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER children 12 years or younger : ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

Allergy alert: Do not use if you are allergic to salicylates (including aspirin) unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this label.
  • rare cases of serious burns have been reported with products of this type
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not use at the same time as other topical analgesics

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily
  • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, aloe barbadensis leaf juice, carbomer, diisopropyl adipate, eucalyptus globulus leaf oil, glycerin, mentha piperita (peppermint) oil, methyl salicylate, SD alcohol 40 (15%), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength
FLEXALL
Pain Relieving Gel
in an Aloe Vera Base
Menthol 16%
Net wT 7 lb (3.17 kg)

PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximum Strength
FLEXALL
Pain Relieving Gel
in an Aloe Vera Base
Menthol 16%
Net wT 7 lb (3.17 kg)

PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)  PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)PRINCIPAL DISPLAY PANEL Maximum Strength FLEXALL Pain Relieving Gel in an Aloe Vera Base Menthol 16% Net wT 7 lb (3.17 kg)

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
63400-160263400-1602-8, 63400-1602-9

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
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
METHYL SALICYLATELAV5U5022YIACT
ALCOHOL3K9958V90MIACT
STEARETH-2V56DFE46J5IACT
STEARETH-2153J3F32P58IACT
THYME OIL2UK410MY6BIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
d60d3889-98f3-888d-e053-2995a90a288ad34b48c2-584c-4d64-b9f9-0933a6833be62022-01-20WarningsExact identifier
spl set id: d34b48c2-584c-4d64-b9f9-0933a6833be6

Reported adverse events (FAERS/openFDA)#

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