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NDC 41167-1601-03 Flexall Pain Relieving 0.07 g/g Details

Flexall Pain Relieving 0.07 g/g

Flexall Pain Relieving is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Chattem, Inc.. The primary component is MENTHOL.

Product Information

NDC	41167-1601
Product ID	41167-1601_92d359ae-379b-4307-b9ca-c761031caf9c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Flexall Pain Relieving
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	0.07
Active Ingredient Units	g/g
Substance Name	MENTHOL
Labeler Name	Chattem, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 41167-1601-03 (41167160103)

Pricing Information	N/A
NDC Package Code	41167-1601-3
Billing NDC	41167160103
Package	1 TUBE in 1 CARTON (41167-1601-3) / 113 g in 1 TUBE
Marketing Start Date	1997-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ee6c280f-b083-4e2e-a412-e3e89ab88c28 Details

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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
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

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: 1/1997

Document Id: 92d359ae-379b-4307-b9ca-c761031caf9c

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

Version: 7

Effective Time: 19970101