Lavender 2 & 4oz

Lavender 2 & 4oz
SPL v5
SPL
SPL Set ID b8197d52-ccfb-b008-e053-2995a90a0a53
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Glucosamine Sulfate Menthyl Lactate, (-)- Glycerin Dimethyl Sulfone Stearyl Alcohol Arginine Caprylyl Glycol Glycol Stearate Phenoxyethanol Hyaluronate Sodium Maltodextrin Water Lavandula Angustifolia Flower Ulva Lactuca Aloe Vera Leaf Almond Oil Isopropyl Myristate Glyceryl Stearate Se Peg-100 Stearate Cannabis Sativa Seed Oil Fucus Vesiculosus

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Active Ingredients Menthol 1.0% w/w


Medication Information

Indications and Usage

Use For temporary relief of pain

Description

Active Ingredients Menthol 1.0% w/w

Section 50565-1

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional.

Section 50569-3

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Active Ingredients

Menthol 1.0% w/w

Warnings

Warnings

For external use only. Avoid contact with eyes.

Questions

Distributed by Marketites LLC

Coral Gables, FL 33134

Made in the USA

Questions? [email protected]

Directions

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 doctor.

Ohter Information

Store in a cool dry place between 68º and 77ºF and relative humidity not exceeding 65%.

Do not use if seal is broken, torn or missing.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Menthyl Lactate, Glycerin, PEG 100 Stearate, Cannabis Sativa Seed Oil, Ulva lactuca Linnaeus, Fucaceae Fucus Vesiculosus, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Lavandula Angustifolia (Lavender) Flower Oil, Maltodextrin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol


Structured Label Content

Indications and Usage (34067-9)

Use For temporary relief of pain

Section 50565-1 (50565-1)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional.

Section 50569-3 (50569-3)

Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days, or new symptoms occur.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Menthol 1.0% w/w

Warnings

Warnings

For external use only. Avoid contact with eyes.

Questions

Distributed by Marketites LLC

Coral Gables, FL 33134

Made in the USA

Questions? [email protected]

Directions

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 doctor.

Ohter Information

Store in a cool dry place between 68º and 77ºF and relative humidity not exceeding 65%.

Do not use if seal is broken, torn or missing.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Water, Stearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Isopropyl Myristate, Glyceryl Stearate, Menthyl Lactate, Glycerin, PEG 100 Stearate, Cannabis Sativa Seed Oil, Ulva lactuca Linnaeus, Fucaceae Fucus Vesiculosus, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Fragrance, Lavandula Angustifolia (Lavender) Flower Oil, Maltodextrin, Glucosamine Sulfate, Dimethyl Sulfone (MSM), L-Arginine, Glycol Stearate, Phenoxyethanol, Caprylyl Glycol


Advanced Ingredient Data


Raw Label Data

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