83391-004 Lidocain Pain Relief Roll-on

83391-004 Lidocain Pain Relief Roll-on
SPL v2
SPL
SPL Set ID 8b30f623-6077-4f2e-8fa4-ce4a298953b5
Route
TOPICAL
Published
Effective Date 2024-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Water Aloe Vera Leaf Cetostearyl Alcohol Ceteth-10 Phosphate Cyclomethicone 5 Dihexadecyl Phosphate Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Edetate Disodium Anhydrous Ethylhexylglycerin Glyceryl Stearate Se Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Lavender Oil Isohexadecane Phenoxyethanol Alcohol Aminomethylpropanol Steareth-21

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-21

Description

Drug Facts

Purpose

Topical Analgestic


Medication Information

Purpose

Topical Analgestic

Description

Drug Facts

Use

Temporarily relieves minor pain

Section 51945-4

Storage

Store it in a dry place at room temperature between 20-25 C (68-77F)

Active I

Lidocaine HCl 4%

Keep Out

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

Directions
  • Apply a thin layer to the affected area every 6 to 8 hours
  • Use no more than three times in a 24-hour period.
Do Not Use
  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • At the same time as other topical analgesics
  • On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin
Inactive Ingredients

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, AminomethyI Propanol, Cetearyl Alcohol, Ceteth-10 Phosphate,Cyclopentasiloxane, DicetyI Phosphate, Dimethicone,Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, SD Alcohol, Steareth-21, Water

Auvon Lidocaine Pain Relief Roll On

Drug Facts

Discontinue Use and Consult A Doctor
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

Structured Label Content

Use

Temporarily relieves minor pain

Section 51945-4 (51945-4)

Purpose

Topical Analgestic

Storage

Store it in a dry place at room temperature between 20-25 C (68-77F)

Active I (Active i)

Lidocaine HCl 4%

Keep Out (Keep out)

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

Directions
  • Apply a thin layer to the affected area every 6 to 8 hours
  • Use no more than three times in a 24-hour period.
Do Not Use (Do not use)
  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • At the same time as other topical analgesics
  • On eyes, mucous membranes, cuts, wounds, damaged, broken, swollen, or irritated skin
Inactive Ingredients (Inactive ingredients)

Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, AminomethyI Propanol, Cetearyl Alcohol, Ceteth-10 Phosphate,Cyclopentasiloxane, DicetyI Phosphate, Dimethicone,Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, SD Alcohol, Steareth-21, Water

Auvon Lidocaine Pain Relief Roll On (AUVON Lidocaine Pain Relief Roll-on)

Drug Facts

Discontinue Use and Consult A Doctor (Discontinue use and consult a doctor)
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

Advanced Ingredient Data


Raw Label Data

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