Private Label Hot/cold Menthol 16% Roll-on

Private Label Hot/cold Menthol 16% Roll-on
SPL v3
SPL
SPL Set ID a8bf9744-9979-13c1-e053-2a95a90a30aa
Route
TOPICAL
Published
Effective Date 2018-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 mg)
Inactive Ingredients
(c10-c30)alkyl Methacrylate Ester Propylene Glycol Trolamine Alcohol Capsaicin Isopropyl Myristate Glycerin Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-21
Description

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Medication Information

Warnings and Precautions

When using this product: 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 pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.

Indications and Usage

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

Dosage and Administration

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Description

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 16%

Equate Label

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

Dosage and Administration (34068-7)

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Warnings and Precautions (34071-1)

When using this product: 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 pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.

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)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 16%

Equate Label

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.895768 · Updated: 2026-03-14T23:02:08.105317