Lidosync

Lidosync
SPL v3
SPL
SPL Set ID 11116755-885e-4cce-bc4c-d87a2baadda4
Route
TOPICAL
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Tartaric Acid Mineral Oil Polysorbate 80 Polyacrylic Acid (250000 Mw) Povidone K90 Propylene Glycol Sodium Polyacrylate (2500000 Mw) Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

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 - [email protected] 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

Purpose

Topical anesthetic Topical analgesic


Medication Information

Indications and Usage

Uses: For temporary relief of pain.

Purpose

Topical anesthetic

Topical analgesic

Description

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 - [email protected] 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

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Section 50570-1

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.

Section 53413-1

​Questions or Comments: 833.711.8833

Section 53414-9

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

Warnings
  • For external use only

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.

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 - [email protected]

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

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

Active Ingredients:

Lidocaine 4%

Menthol 1%

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.

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 PATCHES

3.94 x 5.5 (10cm x 14cm)

ION PHARMA


Structured Label Content

Indications and Usage (34067-9)

Uses: For temporary relief of pain.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product:

  • Use only as directed
  • Avoid contact with the eyes, mucous membranes or rashes
  • Do not bandage tightly

Section 50570-1 (50570-1)

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.

Section 53413-1 (53413-1)

​Questions or Comments: 833.711.8833

Section 53414-9 (53414-9)

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

Purpose

Topical anesthetic

Topical analgesic

Warnings
  • For external use only

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.

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 - [email protected]

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

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

Active Ingredients: (Active ingredients:)

Lidocaine 4%

Menthol 1%

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.

Principal Display Panel (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 PATCHES

3.94 x 5.5 (10cm x 14cm)

ION PHARMA


Advanced Ingredient Data


Raw Label Data

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