Maxocaine Pain Relieving Roll-on

Maxocaine Pain Relieving Roll-on
SPL v3
SPL
SPL Set ID c263d5f2-89b9-4dfd-91c8-f894e5f956c9
Route
TOPICAL
Published
Effective Date 2018-03-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Aloe Vera Leaf Water Arnica Montana Indian Frankincense Cetyl Alcohol Ethylhexylglycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Dimethyl Sulfone Phenoxyethanol Polysorbate 20 Sodium Lauryl Sulfate Stearic Acid Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-01

Description

Lydocaine HCL 4% Menthol 1%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lydocaine HCL 4% Menthol 1%

Use:

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Warnings:
  • For external use only
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions:

 Apply to affected area not more than three to four times daily.  consult a physician. Adults and children two-years of age or older: Chinldren under two-years of age: 

Do Not Apply
  • to wounds or damaged skin.
  • Do not bandage tightly.
Active Ingredient

Lydocaine HCL 4%

Menthol 1%

Package Labeling:

Inactive Information:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding,

contact physician prior to use.

Keep Out of Reach of Children.

If swallowed, consult physician.


Structured Label Content

Use:

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.

Purpose

Topical anesthetic

Warnings:
  • For external use only
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Directions:

 Apply to affected area not more than three to four times daily.  consult a physician. Adults and children two-years of age or older: Chinldren under two-years of age: 

Do Not Apply (Do not apply)
  • to wounds or damaged skin.
  • Do not bandage tightly.
Active Ingredient

Lydocaine HCL 4%

Menthol 1%

Package Labeling:

Inactive Information:

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, Boswellia Serrata Extract, Cetyl Alcohol, Ethylhexylglycerin, Ilex Paraguayensis (Yerba Mate') Extract, Isopropyl Alcohol, Isopropyl Myristate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine

Additional Information:

Store at room temperature.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

contact physician prior to use.

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

If swallowed, consult physician.


Advanced Ingredient Data


Raw Label Data

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