Csi, Lidocaine And Menthol, Pain Relief Gel-roll On, 2.5 Fl. Oz / 73 Ml, Gel, Bottle

Csi, Lidocaine And Menthol, Pain Relief Gel-roll On, 2.5 Fl. Oz / 73 Ml, Gel, Bottle
SPL v4
SPL
SPL Set ID f02fa9c0-b8af-f362-e053-2a95a90ae516
Route
TOPICAL
Published
Effective Date 2022-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g) Menthol (0.01 g)
Inactive Ingredients
Polyacrylic Acid (250000 Mw) Water Lavender Oil Phenoxyethanol Isopropyl Myristate .alpha.-tocopherol, D- Aloe Vera Leaf Propylene Glycol Tartaric Acid Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-22

Description

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic) Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Purpose

(Lidocaine) Topical Anesthetic (Menthol) Topical Analgesic


Medication Information

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Description

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic) Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Use

temporary relief of pain

Section 34072-9

Child-resistant packaging. Close cap tightly after use.

Section 51945-4

Warnings

For external use only

Flammable

• keep away from fire or flame

Directions

Adults and children 12 over years :

• apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period

Children under 12 years of age : Consult a doctor

Do Not Use

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

Stop Use If

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Ask A Doctor If

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Inactive Ingredients

Aloe Vera Extract, Carbopol, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

Questions Or Comments

86-21-31166566

When Using This Product

• use only as directed. Read and follow all directions and warnings on this label • do not allow contact with eyes and mucous membranes • do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • do not use at the same time as other topical analgesics

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 right away


Structured Label Content

Use

temporary relief of pain

Section 34072-9 (34072-9)

Child-resistant packaging. Close cap tightly after use.

Section 51945-4 (51945-4)

Purpose

(Lidocaine) Topical Anesthetic

(Menthol) Topical Analgesic

Warnings

For external use only

Flammable

• keep away from fire or flame

Directions

Adults and children 12 over years :

• apply a thin layer to affected area 6 to 8 hours, not to exceed 3 application in a 24 hour period

Children under 12 years of age : Consult a doctor

Do Not Use (Do not use)

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

Stop Use If (Stop use if)

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Ask A Doctor If (Ask a doctor if)

• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur within a few days

Active Ingredient

Lidocaine 4.0% (w/w ...... Purpose: Topical Anesthetic)

Menthol 1.0% (w/w ...... Purpose: Topical Analgesic)

Inactive Ingredients

Aloe Vera Extract, Carbopol, Isopropyl myristate, Lavender Oil, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tartaric acid, Vitamin E, Water

Questions Or Comments (Questions or Comments)

86-21-31166566

When Using This Product (When using this product)

• use only as directed. Read and follow all directions and warnings on this label • do not allow contact with eyes and mucous membranes • do not bandage or apply local heat (such as heating patches) or a medicated patch to the area of use • do not use at the same time as other topical analgesics

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 right away


Advanced Ingredient Data


Raw Label Data

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