SPL v4
SPL
SPL Set ID bbbe4a23-17ba-64d6-e053-2a95a90ac801
Route
TOPICAL
Published
Effective Date 2021-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Silicon Dioxide .alpha.-tocopherol Acetate Water Arctium Lappa Root Isopropyl Alcohol Fd&c Yellow No. 5 Camphor (natural) Carbomer 934 Glycerin Frankincense Calendula Officinalis Flower Fd&c Blue No. 1 Ilex Paraguariensis Leaf Isopropyl Myristate Green Tea Leaf Trolamine Arnica Montana Flower Brilliant Blue G Melissa Officinalis Leaf Aloe Vera Leaf Sorbic Acid

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-01

Description

Menthol 4%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Menthol 4%

Uses

Temporary relief from minor aches and pains of sore muscles and

joints associated with •arthritis •backache •strains •sprains

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Directions

Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary

Children under 2 years of age: consult physician

Active Ingredient

Menthol 4%

Other Information

• store in a cool dry place

Inactive Ingredients

aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

Questions Or Comments

1-856-357-7321

When Using This Product

• avoid contact with the 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 or if excessive irritation develops

• do not bandage

• wash hands after use with cool water

• do not use with heating pad or device

Stop Use and Ask A Doctor If

condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

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 (1-800-222-1222) immediately

Ask A Doctor Before Use If You Have

sensitive skin

Pain Relief Cold Therapy Gel 3 Fl Oz


Structured Label Content

Uses

Temporary relief from minor aches and pains of sore muscles and

joints associated with •arthritis •backache •strains •sprains

Purpose

Cooling Pain Relief

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Directions

Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary

Children under 2 years of age: consult physician

Active Ingredient

Menthol 4%

Other Information

• store in a cool dry place

Inactive Ingredients (Inactive ingredients)

aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine

Questions Or Comments (Questions or comments)

1-856-357-7321

When Using This Product (When using this product)

• avoid contact with the 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 or if excessive irritation develops

• do not bandage

• wash hands after use with cool water

• do not use with heating pad or device

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

condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

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 (1-800-222-1222) immediately

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

sensitive skin

Pain Relief Cold Therapy Gel 3 Fl Oz (Pain Relief Cold Therapy Gel 3 FL OZ)


Advanced Ingredient Data


Raw Label Data

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