80465-008-01

80465-008-01
SPL v2
SPL
SPL Set ID ec1a2a1f-a38d-9c59-e053-2a95a90ad268
Route
TOPICAL
Published
Effective Date 2024-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 g)
Inactive Ingredients
Isopropyl Myristate Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-19

Description

Menthol 8%


Medication Information

Warnings and Precautions

For external use only. · Ask a doctor before use if you have redness over affected area.

Description

Menthol 8%

Uses:

Aid for temporary local relief of minor pain in muscles or joints.

Section 50565-1

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

Section 50566-9

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7

Use only as directed.

Do not bandage tightly or use with a heating pad.

Avoid contact with eyes and mucous membranes.

Do not apply to wounds or damaged, broken, or irritated skin.

A transient burning sensation or redness may occur upon application but generally disappears in several days.

If you experience an allergic reaction, discontinue use, and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

Section 51727-6

Isopropyl Myristate, Fragrance (Parfum), Limonene, Pimpinella Anisum (Aniseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Oil, Ocimum Basilicum (Basil) Oil.

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 8%

Directions:

Adults and Children over 12 years of age

Apply a small amount on the affected area.

Massage in circular motion, Let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

Natureance Miracle Oil


Structured Label Content

Uses: (USES:)

Aid for temporary local relief of minor pain in muscles or joints.

Warnings and Precautions (34071-1)

For external use only. · Ask a doctor before use if you have redness over affected area.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Section 50567-7 (50567-7)

Use only as directed.

Do not bandage tightly or use with a heating pad.

Avoid contact with eyes and mucous membranes.

Do not apply to wounds or damaged, broken, or irritated skin.

A transient burning sensation or redness may occur upon application but generally disappears in several days.

If you experience an allergic reaction, discontinue use, and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

Section 51727-6 (51727-6)

Isopropyl Myristate, Fragrance (Parfum), Limonene, Pimpinella Anisum (Aniseed) Seed Oil, Mentha Piperita (Peppermint) Oil, Citrus Aurantium Dulcis (Orange) Oil, Eucalyptus Oil, Ocimum Basilicum (Basil) Oil.

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 8%

Directions: (DIRECTIONS:)

Adults and Children over 12 years of age

Apply a small amount on the affected area.

Massage in circular motion, Let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

Children under 12 years of age: do not use, consult a doctor.

Natureance Miracle Oil (NATUREANCE - MIRACLE OIL)


Advanced Ingredient Data


Raw Label Data

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