73647-401-03

73647-401-03
SPL v1
SPL
SPL Set ID 44786cb6-176e-cc6e-e063-6394a90a54ad
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Sorbic Acid Methyl Salicylate Cannabis Sativa Seed Oil Water Glycerin Salicylic Acid Carbomer 940 Sodium Hydroxide Ceteareth-25 Benzyl Alcohol Alcohol Calendula Officinalis Flower Fd&c Blue No. 1 Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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 and joints.

Section 50565-1

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

Section 50567-7



• Avoid contact with the eyes or mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not apply to the irritated skin or if excessive irritation develops.

• Do not bandage tightly.

• Do not use with heating pad or device.

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

Section 51727-6

Water (Aqua), Alcohol Denat, Ceteareth-25, Caprylic/Capric Triglyceride, Glycerin, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Blue No.1 (CI 42090).

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol ………………………………...…………………………….…. 4%

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

Other Information

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

Questions Or Comments?

Contact us +1-833-458-7822

If Pregnant Or Breast Feeding

Ask a health professional before use.

Just Cbd Roll On Cooling Gel +1500


Structured Label Content

Use

Aid for temporary local relief of minor pain in muscles and 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 50567-7 (50567-7)



• Avoid contact with the eyes or mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not apply to the irritated skin or if excessive irritation develops.

• Do not bandage tightly.

• Do not use with heating pad or device.

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

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Ceteareth-25, Caprylic/Capric Triglyceride, Glycerin, Calendula Officinalis Extract, Cannabis Sativa Seed Oil, Carbomer, Sodium Hydroxide, Methyl Salicylate, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Blue No.1 (CI 42090).

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol ………………………………...…………………………….…. 4%

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

Other Information (Other information)

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

Questions Or Comments? (Questions or comments?)

Contact us +1-833-458-7822

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

Ask a health professional before use.

Just Cbd Roll On Cooling Gel +1500 (JUST CBD ROLL-ON COOLING GEL +1500)


Advanced Ingredient Data


Raw Label Data

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