Flexall Max

Flexall Max
SPL v1
SPL
SPL Set ID 79dd238d-87fe-4d89-bb3f-2677cae25993
Route
TOPICAL
Published
Effective Date 2011-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.16 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Diisopropyl Adipate Glycerin Peppermint Oil Methyl Salicylate Steareth-2 Steareth-21 Thyme Oil .alpha.-tocopherol Acetate, D- Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1997-01-01

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Section 42229-5

Drug Facts

Warnings

For external use only

Allergy alert:

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

Do Not Use

if you are allergic to salicylates (including aspirin) unless directed by a doctor.

Active Ingredient

Menthol 16%

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

Maximum Strength

Flexall®

Pain Relieving Gel In An Aloe Vera Base

Menthol 16%

Net wt 3 oz (85 g)

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.


Structured Label Content

Uses

temporarily relieves minor pain associated with:

  • arthritis

  • simple backache

  • muscle strains

  • sprains

  • bruises

  • cramps
Section 42229-5 (42229-5)

Drug Facts

Purpose

Topical analgesic

Warnings

For external use only

Allergy alert:

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

Do Not Use (do not use)

if you are allergic to salicylates (including aspirin) unless directed by a doctor.

Active Ingredient (Active ingredient)

Menthol 16%

Inactive Ingredients (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 (PRINCIPAL DISPLAY PANEL)

Maximum Strength

Flexall®

Pain Relieving Gel In An Aloe Vera Base

Menthol 16%

Net wt 3 oz (85 g)

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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