Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ea1c78b3-7ae2-47b4-b45a-0c7fc623e592
Route
TOPICAL
Published
Effective Date 2023-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Carbomer Copolymer Type B (allyl Pentaerythritol Crosslinked) Alcohol Aloe Vera Leaf Aminomethylpropanol Caprylyl Trisiloxane Cetostearyl Alcohol Ceteth-20 Phosphate Dihexadecyl Phosphate Dimethicone Edetate Disodium Ethylhexylglycerin Glyceryl Monostearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Isohexadecane Lavender Oil Methylparaben Polysorbate 60 Steareth-2 Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-22

Description

Lidocaine HCl 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine HCl 4%

Use
  • For the temporary relief of pain
Warnings

For external use only

Directions
  • adults and children 12 years of age and over:
  • 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 or younger:ask a doctor

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 Ingredient

Lidocaine HCl 4%

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients

Acrylates/C10-30 Acrylate Crosspolymer, Alcohol Denatured, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Polysorbate 60, Steareth-2, Steareth-21, Water

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 area of use
Stop Use and Ask A Doctor If
  • conditions worsen
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • symptoms persist for more than 7 days
  • symptoms dear up and occur again within a few days

Flammable: Keep away from fire or flame

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children and Pets.

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

Principal Display Panel – 73 Ml Bottle Label

CVS

Health ®

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine Pain

Relief Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

With calming

lavender

aromatherapy

2.5 FL OZ (73 mL)

Principal Display Panel – 73 Ml Carton Label

CVS

Health ®

Compare to the active

ingredient in Aspercreme ®

Lidocaine with Lavender

Essential Oil*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

  • Temporary relief of pain
  • Helps numb pain-affected

    areas without irritation
  • Non-greasy, no-mess formula

With calming

lavender

aromatherapy

Actual Bottle

Size on

Side Panel

2.5 FL OZ

(73 mL)


Structured Label Content

Use
  • For the temporary relief of pain
Purpose

Topical anesthetic

Warnings

For external use only

Directions
  • adults and children 12 years of age and over:
  • 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 or younger:ask a doctor

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 Ingredient (Active ingredient)

Lidocaine HCl 4%

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Store with lid closed tightly
Inactive Ingredients (Inactive ingredients)

Acrylates/C10-30 Acrylate Crosspolymer, Alcohol Denatured, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Polysorbate 60, Steareth-2, Steareth-21, Water

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 area of use
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsen
  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • symptoms persist for more than 7 days
  • symptoms dear up and occur again within a few days

Flammable: Keep away from fire or flame

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

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

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

Principal Display Panel – 73 Ml Bottle Label (Principal Display Panel – 73 mL Bottle Label)

CVS

Health ®

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine Pain

Relief Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

With calming

lavender

aromatherapy

2.5 FL OZ (73 mL)

Principal Display Panel – 73 Ml Carton Label (Principal Display Panel – 73 mL Carton Label)

CVS

Health ®

Compare to the active

ingredient in Aspercreme ®

Lidocaine with Lavender

Essential Oil*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Roll-On

LIDOCAINE HCI 4%

Lavender Essential Oil

  • Temporary relief of pain
  • Helps numb pain-affected

    areas without irritation
  • Non-greasy, no-mess formula

With calming

lavender

aromatherapy

Actual Bottle

Size on

Side Panel

2.5 FL OZ

(73 mL)


Advanced Ingredient Data


Raw Label Data

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