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Flexall Plus

Dosage form: gel
Ingredients: MENTHOL 0.16g in 1g, CAMPHOR (SYNTHETIC) 0.031g in 1g, METHYL SALICYLATE 0.1g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-1603

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 Plus

Drug Facts

Active ingredients

Camphor 3.1%

Menthol 16%

Methyl salicylate 10%

Purpose

Topical

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • muscle 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 carton.
  • 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 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, SD alcohol 40 (15% w/w), steareth-2, steareth-21, thymus vulgaris (thyme) oil, tocopheryl acetate, triethanolamine, water (309-155)

PRINCIPAL DISPLAY PANEL

Maximum Strength
Flexall® Plus
Pain Relieving Gel in an Aloe Vera Base
Net wt 4 oz (113 g)

FLEXALL PLUS 
menthol and camphor and methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1603
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.16 g  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.031 g  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
DIISOPROPYL ADIPATE 
EUCALYPTUS GLOBULUS LEAF 
PEPPERMINT OIL 
STEARETH-2 
STEARETH-21 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-1603-157 g in 1 BOTTLE
2NDC:41167-1603-4113 g in 1 TUBE
3NDC:41167-1603-557 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/01/1997
Labeler - Chattem, Inc. (003336013)

Revised: 08/2017
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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