SPL v2
SPL
SPL Set ID 01f8795b-9f95-c793-e063-6394a90a8330
Route
TOPICAL
Published
Effective Date 2023-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.35 g)
Inactive Ingredients
Xanthan Gum Sodium Benzoate Dehydroacetic Acid Benzyl Alcohol Jojoba Oil Peg-8 Beeswax Almond Oil Rosemary Oil Rice Bran Oil Shea Butter Cannabidiol Arnica Montana Flower Water Maranta Arundinacea Root Water Cedrus Atlantica Wood Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-01

Description

Menthol...........1.4%

Purpose

Menthol 1.4%.........................Topical Analgesic


Medication Information

Purpose

Menthol 1.4%.........................Topical Analgesic

Description

Menthol...........1.4%

Uses

Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

Warnings

FOR EXTERNAL USE ONLY, provides penetrating pain relief

Jar Label

Top Label

Directions

Adults and children 12 years and over; apply to the affected area one to four times daily

Children 12 years and younger; ask a doctor

Other Information

Store at 68-77 degrees F, Avoid direct sunlight

Active Ingredients

Menthol...........1.4%

Inactive Ingredients

Arnica Montana oil, Arrowroot powder, Beeswax, Benzyl alcohol, Cannabidiol, Cedarwood oil, Dehydroacetic acid, Jojoba oil, Rice bran oil, Rosemary oil, Shea butter, Sodium Benzoate, Sweet almond oil, water, Xanthan Gum.

In Case of An Overdose

seek medical help or contact a poison control center right away

Sample Size Back Label

Sample Size Front Label

When Using This Product

Do not apply to wounds or irritated skin, and avoid contact with eyes

If Pregnant Or Breastfeeding

Consult a health professional before use

Stop Use and Ask A Doctor If

The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs

Keep Out of Reach of Children

keep out of reach of children


Structured Label Content

Uses

Temporary relief of aches and pains associated with arthritis, backache, joint pain, muscle strains, and sprains

Purpose

Menthol 1.4%.........................Topical Analgesic

Warnings

FOR EXTERNAL USE ONLY, provides penetrating pain relief

Jar Label (Jar label)

Top Label (Top label)

Directions

Adults and children 12 years and over; apply to the affected area one to four times daily

Children 12 years and younger; ask a doctor

Other Information (Other information)

Store at 68-77 degrees F, Avoid direct sunlight

Active Ingredients

Menthol...........1.4%

Inactive Ingredients (Inactive ingredients)

Arnica Montana oil, Arrowroot powder, Beeswax, Benzyl alcohol, Cannabidiol, Cedarwood oil, Dehydroacetic acid, Jojoba oil, Rice bran oil, Rosemary oil, Shea butter, Sodium Benzoate, Sweet almond oil, water, Xanthan Gum.

In Case of An Overdose (In case of an overdose)

seek medical help or contact a poison control center right away

Sample Size Back Label (sample size Back label)

Sample Size Front Label (Sample size Front label)

When Using This Product (When using this product)

Do not apply to wounds or irritated skin, and avoid contact with eyes

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Consult a health professional before use

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

The condition worsens, symptoms last more than 7 days, the condition clears but occurs again within a few days, Rash or irritation occurs

Keep Out of Reach of Children (Keep out of reach of children)

keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)