Lidosync Cream (lidocaine 4%, Menthol 1%)

Lidosync Cream (lidocaine 4%, Menthol 1%)
SPL v1
SPL
SPL Set ID 200f883c-439a-3b99-e063-6394a90aed10
Route
TOPICAL
Published
Effective Date 2024-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3.1 g) Levomenthol (0.8 g)
Inactive Ingredients
Phenoxyethanol Glyceryl 1-stearate Ethylhexylglycerin Steareth-21 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Dihexadecyl Phosphate Aminomethylpropanol Dimethicone 350 Ceteth-10 Phosphate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Alcohol 95% Water Cyclomethicone 5 Cetostearyl Alcohol Aloe Vera Leaf Isohexadecane Edetate Disodium Anhydrous

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-03

Description

Active ingredients: Purpose: Lidocaine HCl 4%...................................Topical Anesthetic Menthol 1%.............................................Topical Analgesic


Medication Information

Dosage and Administration

Directions:

Adults, or children over the age of 12: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

Children 12 years and younger: ask a doctor

Description

Active ingredients: Purpose: Lidocaine HCl 4%...................................Topical Anesthetic Menthol 1%.............................................Topical Analgesic

Uses

Uses: For Temporary relief of pain.

Inactive Ingredients

Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl

Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer,

Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

Lidosync Package Label

Lidosync When Using Section

When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use

Lidosync Warnings Do Not Use

Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

Questions Or Comments Section

Questions or Comments?

Call 833.711.8833 • [email protected]

Lidosync Drug Facts Active Ingredients

Active ingredients: Purpose:

Lidocaine HCl 4%...................................Topical Anesthetic

Menthol 1%.............................................Topical Analgesic

Lidosync If Pregnant Or Breastfeeding Section

If pregnant or breastfeeding: Ask a health professional before use.

Lidosync Stop Use and Consult Doctor If Section

Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

Lidosync Keep Out of Reach of Children and Pets Section

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control

Center right away.


Structured Label Content

Uses

Uses: For Temporary relief of pain.

Dosage and Administration (34068-7)

Directions:

Adults, or children over the age of 12: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

Children 12 years and younger: ask a doctor

Inactive Ingredients

Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl

Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer,

Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

Lidosync Package Label

Lidosync When Using Section (LidoSync When using section)

When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use

Lidosync Warnings Do Not Use (LidoSync Warnings Do Not Use)

Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

Questions Or Comments Section (Questions or comments section)

Questions or Comments?

Call 833.711.8833 • [email protected]

Lidosync Drug Facts Active Ingredients (LidoSync Drug Facts Active Ingredients)

Active ingredients: Purpose:

Lidocaine HCl 4%...................................Topical Anesthetic

Menthol 1%.............................................Topical Analgesic

Lidosync If Pregnant Or Breastfeeding Section (LidoSync If pregnant or breastfeeding section)

If pregnant or breastfeeding: Ask a health professional before use.

Lidosync Stop Use and Consult Doctor If Section (LidoSync Stop use and consult doctor if section)

Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

Lidosync Keep Out of Reach of Children and Pets Section (Lidosync keep out of reach of children and pets section)

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control

Center right away.


Advanced Ingredient Data


Raw Label Data

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