instaflex pain relieving roll-on

instaflex pain relieving roll-on
SPL v1
SPL
SPL Set ID 957686cc-43ec-6163-e053-2a95a90ad430
Route
topical
Published
Effective Date 2019-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (12.5 mg)
Inactive Ingredients
corn oil phenoxyethanol ethylhexylglycerin polysorbate 20 sodium hydroxide steareth-20 water orange oil eucalyptus oil glyceryl stearate se xanthan gum propanediol carbomer interpolymer type a (allyl sucrose crosslinked) cetyl alcohol dimethicone

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-10-21

Purpose

Menthol (1.25%)....................Topical Analgesic

Description

Menthol (1.25%)


Medication Information

Warnings

For external use only

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

  • arthritis
  • strains
  • sprains
  • bruises
Purpose

Menthol (1.25%)....................Topical Analgesic

Directions

Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.

Children under 12 years of age: Consult a doctor.

Other Information

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol

Description

Menthol (1.25%)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • skin redness or excessive skin irritation develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again in a few days
Section 50567-7

When using this product

  • Use only as directed
  • avoid contact with eyes
  • do not bandage tightly
Section 50569-3

Ask a doctor before use if you have redness over the affected area

Section 50570-1

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin
Section 51945-4

DOCTOR DEVELOPED

FAST ACTING

PAIN RELIEVING ROLL-ON

Instaflex

PAIN RELIEF

Formualted with an Exclusive Oxygenated Oil

Powerful roll-on relief for arthritis, joint & muscle pain

  • Deep Penetrating
  • Fast Acting
  • Pleasant Smelling
  • Non-Greasy
  • No Mess

Net wt. 2.5 oz (71 g)

Active Ingredient

Menthol (1.25%)


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with

  • arthritis
  • strains
  • sprains
  • bruises
Purpose

Menthol (1.25%)....................Topical Analgesic

Directions

Adult and children 12 years of age and older: Apply to affected area no more than 3-4 times daily.

Children under 12 years of age: Consult a doctor.

Other Information (Other information)

Keep product at room termperature and humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. Lot Number and Expiration Date printed below.

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Alcohol, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, Ethylhexylglycerin, Eucalyptus Globulus Oil, Clyceryl Stearate SE, Oxygenated Corn Oil, Phenoxyethanol, Polysorbate-20, Sodium Hydroxide, Steareth-20, Water, Xanthan Gum, Zemea (Corn) Propanediol

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • skin redness or excessive skin irritation develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again in a few days
Section 50567-7 (50567-7)

When using this product

  • Use only as directed
  • avoid contact with eyes
  • do not bandage tightly
Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area

Section 50570-1 (50570-1)

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin
Section 51945-4 (51945-4)

DOCTOR DEVELOPED

FAST ACTING

PAIN RELIEVING ROLL-ON

Instaflex

PAIN RELIEF

Formualted with an Exclusive Oxygenated Oil

Powerful roll-on relief for arthritis, joint & muscle pain

  • Deep Penetrating
  • Fast Acting
  • Pleasant Smelling
  • Non-Greasy
  • No Mess

Net wt. 2.5 oz (71 g)

Active Ingredient

Menthol (1.25%)


Advanced Ingredient Data


Raw Label Data

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