Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 29ebc5dd-9d57-43b4-a7ce-4ea6d8b280cb
Route
TOPICAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (41 mg) Menthol (9 mg)
Inactive Ingredients
Carbomer Copolymer Type A Aloe Vera Leaf Aminomethylpropanol Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Water Dimethicone Caprylyl Trisiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Edetate Disodium Ethylhexylglycerin Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Polysorbate 60 Methylparaben Sodium Alcohol Steareth-21

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-14

Description

Lidocaine HCl 4% Menthol 1%

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic

Topical analgesic

Description

Lidocaine HCl 4% Menthol 1%

Uses

temporarily relieves minor pain

Warnings

For external use only

  • Avoid contact with eyes or mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad
Directions

Rub on affected area - repeat 3 to 4 times daily

  • for adults and children 12 or over
  • under 12 consult doctor before 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
Other Information
  • This product may cause allergic reaction in some individuals. Test on small area before use.
Active Ingredients

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients

Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized Water, Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

Stop Use and Ask A Doctor If
  • Condition worsens
  • servere skin irritation occurs
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
Ask A Doctor Before Use If You
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel – 73.9 Ml Carton Label

CVS

Health
®

Compare to active

ingredients in IcyHot ®

Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting & long lasting
  • Desensitizes

    aggravated nerves

Among over the counter

topical analgesics.

Actual Bottle Size

on Side Panel

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 Ml Container Label

CVS

Health
®

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting &

    long lasting
  • Desensitizes

    aggravated nerves

2.5 FL OZ (73.9 mL)


Structured Label Content

Uses

temporarily relieves minor pain

Purpose

Topical anesthetic

Topical analgesic

Warnings

For external use only

  • Avoid contact with eyes or mucous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad
Directions

Rub on affected area - repeat 3 to 4 times daily

  • for adults and children 12 or over
  • under 12 consult doctor before use
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
Other Information (Other information)
  • This product may cause allergic reaction in some individuals. Test on small area before use.
Active Ingredients (Active ingredients)

Lidocaine HCl 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized Water, Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • servere skin irritation occurs
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • Have sensitive skin
  • Are pregnant or breastfeeding
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel – 73.9 Ml Carton Label (Principal Display Panel – 73.9 mL Carton Label)

CVS

Health
®

Compare to active

ingredients in IcyHot ®

Lidocaine Plus Menthol*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting & long lasting
  • Desensitizes

    aggravated nerves

Among over the counter

topical analgesics.

Actual Bottle Size

on Side Panel

2.5 FL OZ (73.9 mL)

Principal Display Panel – 73.9 Ml Container Label (Principal Display Panel – 73.9 mL Container Label)

CVS

Health
®

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

PLUS MENTHOL

LIDOCAINE HCl 4%

MENTHOL 1%

  • Safe & effective
  • Fast acting &

    long lasting
  • Desensitizes

    aggravated nerves

2.5 FL OZ (73.9 mL)


Advanced Ingredient Data


Raw Label Data

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