FLEXALL PAIN RELIEVING- menthol gel
Chattem, Inc.

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-1601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
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, D- (UNII: A7E6112E4N)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-1601-3	1 in 1 CARTON	01/01/1997	06/30/2023
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:41167-1601-4	453 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/1997	01/02/1997
3	NDC:41167-1601-5	3170 g in 1 DRUM; Type 0: Not a Combination Product	01/01/1997	01/02/1997

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/01/1997	06/30/2023

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
CHATTEM, INC.		003336013	analysis(41167-1601) , label(41167-1601) , manufacture(41167-1601) , pack(41167-1601)

Revised: 7/2023

Document Id: 1d0b5e6f-fd8e-4e40-a617-07d195761548

Set id: ee6c280f-b083-4e2e-a412-e3e89ab88c28

Version: 8

Effective Time: 20230719

Chattem, Inc.