85110-003-03

85110-003-03
SPL v1
SPL
SPL Set ID 42fb0bdf-8bbd-bbe3-e063-6294a90a656c
Route
TOPICAL
Published
Effective Date 2025-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g)
Inactive Ingredients
Water Alcohol Propylene Glycol Polysorbate 20 Glycerin Arnica Montana Flower Polyacrylamide (1500 Mw) C13-14 Isoparaffin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s At 1.0%) Laureth-7 Sodium Hydroxide Edetate Disodium Benzyl Alcohol Salicylic Acid Sorbic Acid Fd&c Yellow No. 6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-28

Description

Menthol ………………………………...…………………………….…. 3%


Medication Information

Warnings and Precautions

• For external use only.

• Ask a doctor before use if you have redness over affected area.

Description

Menthol ………………………………...…………………………….…. 3%

Uses

For temporary relief of minor aches and pains 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, Propylene Glycol, Polysorbate 20, Glycerin, Arnica Montana Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-7, Sodium Hydroxide, Disodium EDTA, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow No.6 (CI 15985).

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol ………………………………...…………………………….…. 3%

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.

Paingel Roll On

Other Information

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

Questions Or Comments?

Contact us +1-307-533-7345

If Pregnant Or Breast Feeding

Ask a health professional before use.


Structured Label Content

Uses

For temporary relief of minor aches and pains 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, Propylene Glycol, Polysorbate 20, Glycerin, Arnica Montana Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Laureth-7, Sodium Hydroxide, Disodium EDTA, Benzyl Alcohol, Salicylic Acid, Sorbic Acid, FD&C Yellow No.6 (CI 15985).

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol ………………………………...…………………………….…. 3%

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.

Paingel Roll On (PAINGEL ROLL-ON)

Other Information (Other information)

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

Questions Or Comments? (Questions or comments?)

Contact us +1-307-533-7345

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

Ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)