SPL v1
SPL
SPL Set ID 9e541811-0a2d-310f-e053-2a95a90ad5b0
Route
TOPICAL
Published
Effective Date 2020-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (8.9 g)
Inactive Ingredients
Isopropyl Alcohol Camphor (synthetic) Propylene Glycol Lavender Oil Hydroxypropyl Cellulose, Unspecified Arnica Montana Alpha-tocopherol Tea Tree Oil Aloe Vera Leaf Thymol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-01-01

Description

Menthol 10%


Medication Information

Warnings and Precautions

For external use only. Flammable, keep away from fire/flame.

Indications and Usage

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

Dosage and Administration

Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction, not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.

Description

Menthol 10%

Section 50565-1

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 10%

Section 60561-8

Store in a cool and dry place with lid closed tightly.

Questions or Comments? E-mail: [email protected] Manufactured and Distributed by: Scientific Solutions Global LLC, Carle Place, NY, USA


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains• bruises • sprains

Dosage and Administration (34068-7)

Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction, not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.

Warnings and Precautions (34071-1)

For external use only. Flammable, keep away from fire/flame.

Section 50565-1 (50565-1)

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 10%

Section 60561-8 (60561-8)

Store in a cool and dry place with lid closed tightly.

Questions or Comments? E-mail: [email protected] Manufactured and Distributed by: Scientific Solutions Global LLC, Carle Place, NY, USA


Advanced Ingredient Data


Raw Label Data

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