theracare 4% lidocaine & 1% menthol cream

theracare 4% lidocaine & 1% menthol cream
SPL v3
SPL
SPL Set ID c80ba251-91a5-0858-e053-2995a90a9cff
Route
topical
Published
Effective Date 2021-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 g) menthol (1 g)
Inactive Ingredients
steareth-21 dimethicone edetate disodium alcohol phenoxyethanol dihexadecyl phosphate ethylhexylglycerin aloe vera leaf isohexadecane hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) cyclomethicone 5 aminomethylpropanol carbomer interpolymer type a (allyl sucrose crosslinked) dimethicone/vinyl dimethicone crosspolymer (soft particle) water glyceryl monostearate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-07-01
Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic Menthol 1%.......................................................................................................................................Topical analgesic

Description

Lidocaine HCL Menthol

Medication Information

Warnings

For external use only. Avoid contact with eyes

Purpose

Lidocaine HCl 4%............................................................................................................................Topical anesthetic Menthol 1%.......................................................................................................................................Topical analgesic

Directions

adults and children over 12 years:

■ apply a thin layer to affected area, not more than 6 to 8 hours, not exceed 3 applications in a 24 hour period.

children 12 years or younger: ask a doctor

Inactive Ingredients

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water

Description

Lidocaine HCL Menthol

Use

temporarily relieves minor pain

Prin

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

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

Active Ingredients

Lidocaine HCL

Menthol

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

Stop Use and Ask A Doctor If

■ condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Structured Label Content

Warnings

For external use only. Avoid contact with eyes

Directions

adults and children over 12 years:

■ apply a thin layer to affected area, not more than 6 to 8 hours, not exceed 3 applications in a 24 hour period.

children 12 years or younger: ask a doctor

Inactive Ingredients (Inactive ingredients)

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water

Use

temporarily relieves minor pain

Prin (PRIN)

Purposes

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

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

Active Ingredients (Active ingredients)

Lidocaine HCL

Menthol

When Using This Product (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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

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

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.027285 · Updated: 2026-03-14T23:02:58.626725