real time pain relief foot cream

real time pain relief foot cream
SPL v1
SPL
SPL Set ID 29c8e06d-9b29-44f9-ac21-9160d06475cb
Route
topical
Published
Effective Date 2024-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (15 mg)
Inactive Ingredients
allantoin aloe vera leaf water ascorbic acid calendula officinalis flower caprylyl glycol ceresin cetostearyl alcohol cetyl alcohol chamomile coriander emu oil eucalyptus oil glycerin st. john's wort lactic acid, unspecified form lanolin melaleuca alternifolia leaf petrolatum phenoxyethanol polysorbate 20 polysorbate 80 vitamin a salix alba bark sodium borate sorbitan sesquioleate stearyl alcohol .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-12

Purpose

Topical Analgesic

Description

Menthol 1.50%


Medication Information

Purpose

Topical Analgesic

Inactive Ingredients

Allantoin, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roamn Chamomile) Oil, Aqua (Deionized Water), Ascorbic Acid (Vitamin-C), Calendula Officinalis Extract, Caprylyl Glycol, Centaurea Cyanus (Cornflower) Extract, Ceresin Wax, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Mantricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycerin, Hydrogenated Vegetable Oil, Hypericum Perforatum (St.John's Wort), Lactic Acid, Lanolin, Melaleuca Alternifolia (Tea Tree) Oil, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-80, Retinyl Palmitate (Vitamin A), Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Borate, SorbitanSesquioleate, Stearyl Alcohol, Tilia Cordata (Linden) Bark Extract, Tocopheryl Acetate (Vitamin E).

Description

Menthol 1.50%

Questions?

877-787-7180

Uses:

For the temporary relief of minor aches and pains of muscle and joints, associated with arthritis, strains, bruises, and sprains.

Warnings:

Do notapply to wounds or damaged skin or bandage tightly.

For external use only.

Drug Facts

Directions:

Adults and Children over 2 years: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Active Ingredient

Menthol 1.50%

Package Labelling:

When Using This Product:

Avoid contact with eyes.

Stop Use and Ask Doctor If:

Condition worsens 

  • 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 swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Topical Analgesic

Inactive Ingredients

Allantoin, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roamn Chamomile) Oil, Aqua (Deionized Water), Ascorbic Acid (Vitamin-C), Calendula Officinalis Extract, Caprylyl Glycol, Centaurea Cyanus (Cornflower) Extract, Ceresin Wax, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Mantricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycerin, Hydrogenated Vegetable Oil, Hypericum Perforatum (St.John's Wort), Lactic Acid, Lanolin, Melaleuca Alternifolia (Tea Tree) Oil, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-80, Retinyl Palmitate (Vitamin A), Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Borate, SorbitanSesquioleate, Stearyl Alcohol, Tilia Cordata (Linden) Bark Extract, Tocopheryl Acetate (Vitamin E).

Questions?

877-787-7180

Uses:

For the temporary relief of minor aches and pains of muscle and joints, associated with arthritis, strains, bruises, and sprains.

Warnings:

Do notapply to wounds or damaged skin or bandage tightly.

For external use only.

Drug Facts

Directions:

Adults and Children over 2 years: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Active Ingredient

Menthol 1.50%

Package Labelling:

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

Avoid contact with eyes.

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

Condition worsens 

  • 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 swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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