zeey menthol pain relief gel-patch, 5 & 15 patches

zeey menthol pain relief gel-patch, 5 & 15 patches
SPL v4
SPL
SPL Set ID 0e6a09cc-7986-f851-e063-6294a90aff67
Route
topical
Published
Effective Date 2024-02-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.05 g)
Inactive Ingredients
arnica montana flower frankincense kaolin tartaric acid water dihydroxyaluminum aminoacetate anhydrous propylene glycol polyacrylic acid (250000 mw) carboxymethylcellulose sodium sodium polyacrylate (2500000 mw) titanium dioxide mineral oil petrolatum hydroxyacetophenone polysorbate 80 glycerin povidone k90 green tea leaf aloe vera leaf edetate disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2024-01-09 Until 2024-01-16

Purpose

Topical Analgesic

Description

Menthol 5.0%


Medication Information

Warnings

For external use only

Purpose

Topical Analgesic

Directions

· Adult and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

· Children under 12 years of age : Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water

Description

Menthol 5.0%

Uses:

Temporary relief from minor aches and pains of sore muscles and joints

associated with: ·arthrits ·backache ·strains ·sprains

Section 44425-7

·Store in a cool dry place away from direct sunlight

Section 51945-4

Active Ingredient

Menthol 5.0%

Questions Or Comments:

1 646-223-0128 ·[email protected]

When Using This Product:

·Use only as directed ·Do not bandage tightly or use with heating pad or device ·Avoid contact with eyes or mucous membranes ·Do not apply to wounds or damaged skin ·Do not use with other ointments, creams, sprays, or liniments ·Do not apply to irritated skin ·Store in a cool dry place away from direct sunlight

Stop Use and Ask A Doctor If:

Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If Pregnant Or Breast Feeding:

Ask a health professional before use

Keep Out of Reach of Children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have:

Sensitive skin


Structured Label Content

Warnings

For external use only

Purpose

Topical Analgesic

Directions

· Adult and Children 12 years of age and older: Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

· Children under 12 years of age : Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water

Uses:

Temporary relief from minor aches and pains of sore muscles and joints

associated with: ·arthrits ·backache ·strains ·sprains

Section 44425-7 (44425-7)

·Store in a cool dry place away from direct sunlight

Section 51945-4 (51945-4)

Active Ingredient

Menthol 5.0%

Questions Or Comments: (Questions or Comments:)

1 646-223-0128 ·[email protected]

When Using This Product: (When using this product:)

·Use only as directed ·Do not bandage tightly or use with heating pad or device ·Avoid contact with eyes or mucous membranes ·Do not apply to wounds or damaged skin ·Do not use with other ointments, creams, sprays, or liniments ·Do not apply to irritated skin ·Store in a cool dry place away from direct sunlight

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If Pregnant Or Breast Feeding: (If pregnant or breast-feeding:)

Ask a health professional before use

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

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have: (Ask a doctor before use if you have:)

Sensitive skin


Advanced Ingredient Data


Raw Label Data

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