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Flexall Pain Relieving by Chattem, Inc.

Medically reviewed on August 14, 2017

Dosage form: gel
Ingredients: MENTHOL 0.07g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-1601

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

Drug Facts

Active ingredient

Menthol 7%

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 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 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, 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 (309-157)

PRINCIPAL DISPLAY PANEL

Vitamin E Enriched
Flexall®
Pain Relieving Gel
Menthol 7%
Net wt 4 oz (113 g)

FLEXALL PAIN RELIEVING 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-1601
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
CARBOXYPOLYMETHYLENE 
EUCALYPTUS OIL 
GLYCERIN 
PEPPERMINT OIL 
METHYL SALICYLATE 
ALCOHOL 
STEARETH-2 
STEARETH-21 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE, D- 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:41167-1601-31 TUBE in 1 CARTON
1113 g in 1 TUBE
2NDC:41167-1601-4453 g in 1 BOTTLE, PUMP
3NDC:41167-1601-53170 g in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/01/1997
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013ANALYSIS(41167-1601), LABEL(41167-1601), MANUFACTURE(41167-1601), PACK(41167-1601)

 
Chattem, Inc.

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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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