SPL v3
SPL
SPL Set ID 29b4fc6d-a588-c1a4-e063-6394a90ae9dd
Route
TOPICAL
Published
Effective Date 2024-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-12-01

Description

Water, Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate80 Povidone K90 Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide.


Medication Information

Description

Water, Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate80 Povidone K90 Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide.

Uses

For temporary relief of pain.

Lable

Stop Use

Stop use and ask a doctor if ● symptoms persist for more than 7 days

● conditions worsen.

● symptoms clear up and occur again within a few days. ● localized skin reactions, such as rash, itching, rednesspain, swelling and blistering develop.

Warnings

Warnings

For external use only

Do not use

* more than 1 patch at a time.

* on wounds, damaged skin or with a heating pad.

* if you are allergic to any ingredients of this product.

Directions

Adults and children 12 years of age and over: ● clean and dry affected area.

● apply 1 patch at a time to affected area, not morethan 3 to 4 times daily. ● remove film from patch and apply to the skin. Children under 12 years of age: consult a doctor

Ask A Doctor

before using on children under 2 years of age.

Other Information

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

Active Ingredients

Active ingredients Purpose Lidocaine 4%---Topical anesthetic

Menthol 1%---Topical anesthetic

Inactive Ingredients

Water, Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate80 Povidone K90 Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide.

When Using This Product

When using this product * use only as directed.

* do not bandage tightly.

* avoid contact with the eyes, mucous membranes or rashes.

Keep Out of Reach of Children

if swallowed, call poison control or seek medical help.


Structured Label Content

Uses

For temporary relief of pain.

Lable

Stop Use (Stop use)

Stop use and ask a doctor if ● symptoms persist for more than 7 days

● conditions worsen.

● symptoms clear up and occur again within a few days. ● localized skin reactions, such as rash, itching, rednesspain, swelling and blistering develop.

Warnings

Warnings

For external use only

Do not use

* more than 1 patch at a time.

* on wounds, damaged skin or with a heating pad.

* if you are allergic to any ingredients of this product.

Directions

Adults and children 12 years of age and over: ● clean and dry affected area.

● apply 1 patch at a time to affected area, not morethan 3 to 4 times daily. ● remove film from patch and apply to the skin. Children under 12 years of age: consult a doctor

Ask A Doctor (Ask a doctor)

before using on children under 2 years of age.

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Active ingredients Purpose Lidocaine 4%---Topical anesthetic

Menthol 1%---Topical anesthetic

Inactive Ingredients

Water, Dihydroxyaluminum Aminoacetate, Glycerol, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate80 Povidone K90 Propylene Glycol, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide.

When Using This Product (When using this product)

When using this product * use only as directed.

* do not bandage tightly.

* avoid contact with the eyes, mucous membranes or rashes.

Keep Out of Reach of Children (Keep out of reach of children)

if swallowed, call poison control or seek medical help.


Advanced Ingredient Data


Raw Label Data

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