FLEXALL PAIN RELIEVING- menthol analgesic gel 
Ari-Med Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Flexall Max

Drug Facts

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

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

Warnings

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

  • 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

  • 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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

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

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)

FLEXALL PAIN RELIEVING 
menthol analgesic gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63400-1602(NDC:41167-1602)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ALCOHOL (UNII: 3K9958V90M)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
THYME OIL (UNII: 2UK410MY6B)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63400-1602-8453 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/1997
2NDC:63400-1602-93170 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/1997
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/199705/31/2021
Labeler - Ari-Med Pharmaceuticals (182612887)

Revised: 1/2022
Document Id: d60d3889-98f3-888d-e053-2995a90a288a
Set id: d34b48c2-584c-4d64-b9f9-0933a6833be6
Version: 6
Effective Time: 20220120
 
Ari-Med Pharmaceuticals