SPL v6
SPL
SPL Set ID c2b427c0-9612-7153-e053-2995a90aa6d0
Route
TOPICAL
Published
Effective Date 2021-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (25 mg)
Inactive Ingredients
Water Pinus Sylvestris Whole Arnica Montana Flower Water Carbomer Homopolymer, Unspecified Type Caprylyl Glycol Citrus Limon Fruit Oil Gaultheria Procumbens Leaf Helianthus Annuus Seed Wax Eucalyptus Globulus Leaf Phenoxyethanol Cinnamomum Camphora Leafy Twig Polysorbate 80 Rosmarinus Officinalis Flowering Top Oil Glycerin Mentha Arvensis Leaf Oil Bentonite

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-05-19

Description

Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80


Medication Information

Warnings and Precautions

For external use only. Use only as directed.

Stop use and ask doctor if - Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product - Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly

Flammable - Keep away from fire or flame.

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints.

Dosage and Administration

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

Description

Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 51727-6

Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 2.5%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only. Use only as directed.

Stop use and ask doctor if - Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

When using this product - Avoid contact with eyes - Do not apply to wounds or damaged skin - Do not bandage tightly

Flammable - Keep away from fire or flame.

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Purified water, Glycerin, Mentha Arvensis Leaf Essential Oil, Helianthus Annuus (Sunflower) Seed Oil, Arnica Montana Flower Extract, Canadian Colloidal Clay, Sodium Carbomer, Caprylyl Glycol, Phenoxyethanol, Citrus Limon (Lemon) Peel Essential Oil, Rosmarinus Officinalis (Rosemary) Leaf Essential Oil, Eucalyptus Globulus Leaf Essential Oil, Gaultheria Procumbens (Wintergreen) Leaf Oil, Pine (Pinus sylvestris) Essential Oil, Cinnamomum Camphora (Camphor) Bark Essential Oil, Polysorbate 80

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 2.5%


Advanced Ingredient Data


Raw Label Data

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