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

Purpose

Topical Analgestic

Description

Drug Facts


Medication Information

Warnings

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

Purpose

Topical Analgestic

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.
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

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.

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
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

Warnings

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

Purpose

Topical Analgestic

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.
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

Use

Temporarily relieves minor pain

Section 51945-4 (51945-4)

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.

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
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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