72937-632-03

72937-632-03
SPL v1
SPL
SPL Set ID 45c5ca6f-d425-6cfb-e063-6394a90a1b66
Route
TOPICAL
Published
Effective Date 2025-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (4 g)
Inactive Ingredients
Ceteareth-25 Medium-chain Triglycerides Alcohol Salicylic Acid Glycerin Carbomer 940 Sorbic Acid Sodium Hydroxide Benzyl Alcohol Calendula Officinalis Flower Methyl Salicylate Cannabis Sativa Seed Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-20

Description

Menthol 4%


Medication Information

Warnings and Precautions

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

Description

Menthol 4%

Use

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

Stop use and ask a doctor if

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.

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

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Carbomer, Sodium Hydroxide, Cannabis Sativa Seed Oil, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid.

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 4%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions

Adults and Children over 12 years

Apply a small amount to 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.

Sunset Pain Relief +350 Hemp Roll On


Structured Label Content

Use (USE)

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)

Stop use and ask a doctor if

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.

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)

Water (Aqua), Alcohol Denat, Ceteareth-25, Glycerin, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Carbomer, Sodium Hydroxide, Cannabis Sativa Seed Oil, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid.

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 4%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Directions (DIRECTIONS)

Adults and Children over 12 years

Apply a small amount to 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.

Sunset Pain Relief +350 Hemp Roll On (SUNSET PAIN RELIEF +350 HEMP ROLL-ON)


Advanced Ingredient Data


Raw Label Data

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