42c70681-494b-47c9-e063-6394a90a80be

Set ID
42c70681-494b-47c9-e063-6394a90a80be
Manufacturer
Bullet point LLC | ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:56

Key Label Information

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose (Lidocaine) Topical Anesthetic (Menthol) Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Use Temporary relief of pain 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. 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 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

Warnings

WARNINGS SECTION

Warnings For external use only

WARNINGS AND PRECAUTIONS SECTION

Flammable • Keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding Ask a health professional before use

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over: Apply a thin layer to the affected area for 6 to 8 hours Not to exceed 3 applications in a 24 hour period Children under 12 years old: Consult a doctor

Other Label Information

INACTIVE INGREDIENT SECTION

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

Products

NDC Codes

Ingredients

NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
LIDOCAINE98PI200987ACTIB
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
MENTHOLL7T10EIP3AACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ALOE VERA LEAFZY81Z83H0XIACT
LAVENDER OILZBP1YXW0H8IACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
POLYSORBATE 806OZP39ZG8HIACT

Complete SPL Sections

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Purpose (Lidocaine) Topical Anesthetic (Menthol) Topical Analgesic

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Use Temporary relief of pain 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. 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 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

OTC - ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

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

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS SECTION

Flammable • Keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children If swallowed, get medical help or contact the Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over: Apply a thin layer to the affected area for 6 to 8 hours Not to exceed 3 applications in a 24 hour period Children under 12 years old: Consult a doctor

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Child-resistant packaging. Close the cap tightly after use.

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

FolderFileDate
otc42c70b4f-638a-658c-e063-6294a90a0ea8.xml2025-11-05
otcPrincipal Display Panel-Menthol Lidocaine.jpg2025-11-05