Equate Lidocaine Cool And Heat Patch 5 Ct

Equate Lidocaine Cool And Heat Patch 5 Ct
SPL v4
SPL
SPL Set ID b86769c3-a0b4-c481-e053-2a95a90af38b
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Glycerin Polyacrylic Acid (250000 Mw) Dihydroxyaluminum Aminoacetate Anhydrous Kaolin Polysorbate 80 Propylene Glycol Povidone, Unspecified Methylparaben Propylparaben Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

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

Description

Lidocaine 4.0% Menthol 1.0%


Medication Information

Description

Lidocaine 4.0% Menthol 1.0%

Uses

Temporarily relieves minor pain

Section 50567-7

Use only as directed

Read and follow all directions and warnings on this carton

Do not allow contact with the eyes

Do not use at the same time as other topical analgesics

Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Do not microwave

Dispose of the used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Section 50570-1

More than one patch on your body at a time.

On cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

If you are allergic to any active or inactive ingredients

If pouch is damaged or opened

Section 51727-6

Aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Section 55105-1

Topical Anesthetic

Topical Anesthetic

Section 55106-9

Lidocaine 4.0%

Menthol 1.0%

Section 60561-8

Store in a clean, dry place outside of direct sunlight. Protect for excessive moisture.

Warnings





For external use only.



Directions

Adults and children 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.

Stop and Ask A Doctor

Condition worsens

Redness is present

Irritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If Pregnant Or Breastfeeding

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 ( 1800-222-1222) right away

Equate Lidocaine + Menthol Pain Relief Patch


Structured Label Content

Uses

Temporarily relieves minor pain

Section 50567-7 (50567-7)

Use only as directed

Read and follow all directions and warnings on this carton

Do not allow contact with the eyes

Do not use at the same time as other topical analgesics

Do not bandage tightly or apply local heat (such as heating pads) to the area of use

Do not microwave

Dispose of the used patch in a manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

More than one patch on your body at a time.

On cut, irritated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

If you are allergic to any active or inactive ingredients

If pouch is damaged or opened

Section 51727-6 (51727-6)

Aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Section 55105-1 (55105-1)

Topical Anesthetic

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4.0%

Menthol 1.0%

Section 60561-8 (60561-8)

Store in a clean, dry place outside of direct sunlight. Protect for excessive moisture.

Warnings (- Warnings)





For external use only.



Directions

Adults and children 12 years of age and over: Clean and the dry affected area. Carefully remove backing from the patch starting at a corner. Apply the sticky side of patch to the affected area. Use one patch for up to 12 hours. Discard patch after a single use. Children under 12 years old of age: consult a physician.

Stop and Ask A Doctor (Stop and ask a doctor)

Condition worsens

Redness is present

Irritation develops

Symptoms persist for more than 7 days or clear up and occur again within a few days

You experience signs of skin injury, such as pain, swelling or blistering where the product was applied

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

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 ( 1800-222-1222) right away

Equate Lidocaine + Menthol Pain Relief Patch


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)