LIDOSYNC Lidocaine 4% Menthol 1% TOPICAL PAIN PATCH For Temporary Pain Relief

Manufacturer
Ion Pharma, LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:56:46

Key Label Information

Active Ingredients And Purpose

Active ingredients:

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical analgesic

Uses

Drug Facts

Active ingredients: Lidocaine 4% Menthol 1% Purpose Topical anesthetic - Topical analgesic INDICATIONS & USAGE Uses: For temporary relief of pain. Warnings For external use only DO NOT USE Do not use: More than one patch on your body at a time - On wounds or damaged skin - For more than one week without consulting a doctor - If you are allergic to any ingredients of this product. WHEN USING When using this product: Use only as directed - Avoid contact with the eyes, mucous membranes or rashes - Do not bandage tightly STOP USE Stop use and consult a doctor if: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - Conditions worsen - Symptoms persist for more than 7 ... PREGNANCY OR BREAST FEEDING If pregnant or breastfeeding: Ask a health professional before use. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. DOSAGE & ADMINISTRATION Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more ... Other Information: Store at 68 °F-77° F (20 °C-25° C.) Store in a clean, dry place without direct sunlight. Inactive Ingredients: Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene ... QUESTIONS ​Questions or Comments: 833.711.8833 - info@ionpharmausa.com PRINCIPAL DISPLAY PANEL NDC 82944-104-10 - LIDOSYNC - Lidocaine 4% Menthol 1% TOPICAL PAIN PATCH - For Temporary Pain Relief - Flexible Patch Innovation - Soothing and Effective - Long Lasting Relief - 10 FLEXIBLE ... INGREDIENTS AND APPEARANCE Product Information

INDICATIONS & USAGE SECTION

Uses: For temporary relief of pain.

Warnings

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use: More than one patch on your body at a time On wounds or damaged skin For more than one week without consulting a doctor If you are allergic to any ingredients of this product.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: Ask a health professional before use.

Directions And Dosage

Directions

Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more than 3 to 4 time daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age: consult a doctor.

Other Label Information

Inactive Ingredients:

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water.

OTC - QUESTIONS SECTION

​Questions or Comments: 833.711.8833 info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

NDC 82944-104-10 ION PHARMA MEDICINE FORWARD LidoSync Topical Analgesic | Drug-in-adhesive Hydrogel Technology Pain Relief Patch ULTRA-THIN & DISCREET 4% LIDOCAINE | 1% MENTHOL PATCH 10 FLEXIBLE PATCHES Patch Size: 5.5 in x 3.94 in (14 cm x 10 cm)

Products

NDC Codes

Ingredients

Complete SPL Sections

Drug Facts

INDICATIONS & USAGE SECTION

Active ingredients: Lidocaine 4% Menthol 1% Purpose Topical anesthetic - Topical analgesic INDICATIONS & USAGE Uses: For temporary relief of pain. Warnings For external use only DO NOT USE Do not use: More than one patch on your body at a time - On wounds or damaged skin - For more than one week without consulting a doctor - If you are allergic to any ingredients of this product. WHEN USING When using this product: Use only as directed - Avoid contact with the eyes, mucous membranes or rashes - Do not bandage tightly STOP USE Stop use and consult a doctor if: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering - Conditions worsen - Symptoms persist for more than 7 ... PREGNANCY OR BREAST FEEDING If pregnant or breastfeeding: Ask a health professional before use. KEEP OUT OF REACH OF CHILDREN Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. DOSAGE & ADMINISTRATION Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more ... Other Information: Store at 68 °F-77° F (20 °C-25° C.) Store in a clean, dry place without direct sunlight. Inactive Ingredients: Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene ... QUESTIONS ​Questions or Comments: 833.711.8833 - info@ionpharmausa.com PRINCIPAL DISPLAY PANEL NDC 82944-104-10 - LIDOSYNC - Lidocaine 4% Menthol 1% TOPICAL PAIN PATCH - For Temporary Pain Relief - Flexible Patch Innovation - Soothing and Effective - Long Lasting Relief - 10 FLEXIBLE ... INGREDIENTS AND APPEARANCE Product Information

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic Topical analgesic

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Uses: For temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

Do not use: More than one patch on your body at a time On wounds or damaged skin For more than one week without consulting a doctor If you are allergic to any ingredients of this product.

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product: Use only as directed Avoid contact with the eyes, mucous membranes or rashes Do not bandage tightly

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and consult a doctor if: Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering Conditions worsen Symptoms persist for more than 7 days Symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: Ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, or children over the age of 12: Clean and dry affected area. Remove film from patch and apply to skin (see illustration). Apply one patch at a time to affected area, not more than 3 to 4 time daily. Remove patch from the skin after at most 8-hour application. Children under 12 years of age: consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away.

Other Information:

OTHER SAFETY INFORMATION

Store at 68 °F-77° F (20 °C-25° C.) Store in a clean, dry place without direct sunlight.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polysorbate 80, Polyacrylic Acid, Polyvinylpyrroliodone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water.

OTC - QUESTIONS SECTION

OTC - QUESTIONS SECTION

​Questions or Comments: 833.711.8833 info@ionpharmausa.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 82944-104-10 ION PHARMA MEDICINE FORWARD LidoSync Topical Analgesic | Drug-in-adhesive Hydrogel Technology Pain Relief Patch ULTRA-THIN & DISCREET 4% LIDOCAINE | 1% MENTHOL PATCH 10 FLEXIBLE PATCHES Patch Size: 5.5 in x 3.94 in (14 cm x 10 cm)

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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Legacy File Index

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otc21c538c7-e180-03cc-e063-6394a90a16aa.xml2024-10-20
otclidosync JPG patch image SPL.jpg2024-10-20
otc1dd6bad5-7c28-48d2-a2ed-6532b1cc843a.xml2024-01-20
otclidosync patch.jpg2024-01-20