Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID c20a4954-df80-4dce-9582-8b49e2a497bb
Route
TOPICAL
Published
Effective Date 2023-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (10 mg) Lidocaine (40 mg)
Inactive Ingredients
Alcohol Medium-chain Triglycerides Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-21

Description

Lidocaine 4% Menthol 1%

Purpose

Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Description

Lidocaine 4% Menthol 1%

Use
  • temporarily relieves minor pain
Warnings

For external use only

Flammable:

  • do not use while smoking or near heat or flame
  • avoid long term storage above 104°F (40°C)
  • do not store at temperatures above 120°F(49°C)
Directions
  • shake well
  • adults and children 12 years of age and older:
  • spray product on area not more than 1 to 3 times daily
  • product will dry quickly on its own, and does not need to be rubbed in

children under 12 years of age or younger:ask a doctor

Do Not Use
  • on large areas of the body
  • on cut, damaged, irritated or swollen skin
  • more than one week without consulting a doctor
Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Alcohol Denatured, Caprylic/Capric Triglyceride, Propylene Glycol

When Using This Product
  • use only as directed
  • rare cases of serious burns have been reported with products of this type
  • do not allow contact with eyes or mucous membranes
  • avoid spraying on face
  • avoid inhalation of spray
  • do not bandage tightly
  • do not use with a heating pad or other topical pain relief products
  • contents under pressure
  • do not puncture or incinerate.
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week
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 – 113 G Can Label

CVS

Health ®

Compare to active

ingredients in IcyHot ®

Lidocaine Dry Spray*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Dry Spray

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes aggravated

    nerves
  • Dries instantly
  • Fast & long-lasting relief
  • No-mess continuous

    spray

SPRAYS AT

ANY ANGLE

NET WT 4 0Z (113 g)


Structured Label Content

Use
  • temporarily relieves minor pain
Purpose

Topical analgesic

Topical analgesic

Warnings

For external use only

Flammable:

  • do not use while smoking or near heat or flame
  • avoid long term storage above 104°F (40°C)
  • do not store at temperatures above 120°F(49°C)
Directions
  • shake well
  • adults and children 12 years of age and older:
  • spray product on area not more than 1 to 3 times daily
  • product will dry quickly on its own, and does not need to be rubbed in

children under 12 years of age or younger:ask a doctor

Do Not Use (Do not use)
  • on large areas of the body
  • on cut, damaged, irritated or swollen skin
  • more than one week without consulting a doctor
Active Ingredients (Active ingredients)

Lidocaine 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Alcohol Denatured, Caprylic/Capric Triglyceride, Propylene Glycol

When Using This Product (When using this product)
  • use only as directed
  • rare cases of serious burns have been reported with products of this type
  • do not allow contact with eyes or mucous membranes
  • avoid spraying on face
  • avoid inhalation of spray
  • do not bandage tightly
  • do not use with a heating pad or other topical pain relief products
  • contents under pressure
  • do not puncture or incinerate.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • needed for longer than a week
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 – 113 G Can Label (Principal Display Panel – 113 g Can Label)

CVS

Health ®

Compare to active

ingredients in IcyHot ®

Lidocaine Dry Spray*

MAXIMUM STRENGTH

Lidocaine concentration

without a prescription

Lidocaine

Pain Relief

Dry Spray

PLUS MENTHOL

LIDOCAINE 4%

MENTHOL 1%

  • Desensitizes aggravated

    nerves
  • Dries instantly
  • Fast & long-lasting relief
  • No-mess continuous

    spray

SPRAYS AT

ANY ANGLE

NET WT 4 0Z (113 g)


Advanced Ingredient Data


Raw Label Data

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