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Flexall Pain Relieving by Proficient Rx LP

Dosage form: gel
Ingredients: MENTHOL 0.16g in 1g
Labeler: Proficient Rx LP
NDC Code: 63187-107

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.

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
do not bandage tightly or use with a heating pad
avoid contact with eyes and mucous membranes
do not apply to wounds or damaged, broken or irritated skin

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

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

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% w/w), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water (234-166)

PRINCIPAL DISPLAY PANEL
FLEXALL PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-107(NDC:41167-1602)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.16 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
DIISOPROPYL ADIPATE 
CORYMBIA CITRIODORA LEAF OIL 
GLYCERIN 
PEPPERMINT OIL 
METHYL SALICYLATE 
STEARETH-2 
STEARETH-21 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63187-107-031 TUBE in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/1997
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079196022RELABEL(63187-107), REPACK(63187-107)

 
Proficient Rx LP

← See all Flexall Pain Relieving brands

Medically reviewed on Jun 6, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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