denticalm massaging roll on

denticalm massaging roll on
SPL v3
SPL
SPL Set ID d677e600-f409-43bd-983e-ddfc96e9d899
Route
topical
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (20 g)
Inactive Ingredients
water magnesium chloride propanediol peg-40 castor oil theanine eucalyptus globulus leaf aloe vera leaf ilex paraguariensis leaf boswellia serrata whole arctium lappa root oil thymus mastichina flowering top oil 1,2-hexanediol caprylhydroxamic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-01

Purpose

Purpose: Topical Analgesic

Description

Menthol 2% Purpose: Topical Analgesic


Medication Information

Warnings

For External Use Only

When using this product:

[bullet] Avoid contact with eyes and mucous membranes

[bullet] Do not apply to wounds or broken skin

[bullet] Do not bandage

[bullet] Do not apply to irritated skin or if excessive skin irritation develops

Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Purpose

Purpose: Topical Analgesic

Directions

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Inactive Ingredients

Water, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

Description

Menthol 2% Purpose: Topical Analgesic

Usage

Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)

Outer Package

NDC 82765-0043-0

Active Ingredient

Menthol 2% Purpose: Topical Analgesic

Dosage & Admnistration

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Keep Out of Reach of Children.

Keep out of reach of children.

Inner Primary Container Label Front and Back

NDC 82765-0043-1


Structured Label Content

Warnings

For External Use Only

When using this product:

[bullet] Avoid contact with eyes and mucous membranes

[bullet] Do not apply to wounds or broken skin

[bullet] Do not bandage

[bullet] Do not apply to irritated skin or if excessive skin irritation develops

Stop use and ask a doctor if conditions worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Purpose

Purpose: Topical Analgesic

Directions

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

Inactive Ingredients

Water, Magnesium Chloride USP, Propanediol, PEG-40 Hydrogenated Castor Oil, L-Theanine, Eucalyptus Globulus Leaf Oil, Aloe Barbadensis Leaf Extract, Ilex Paraguariensis Leaf Extract, Boswellia Serrata Oil, Arctium Lappa Root Extract, Thymus Mastichina Flower Oil, 1,2-Hexanediol, Caprylhydroxamic Acid

Usage

Temporary relief from minor aches and pains of sore muscles and joints associated with teeth grinding and clenching (bruxism)

Outer Package

NDC 82765-0043-0

Active Ingredient

Menthol 2% Purpose: Topical Analgesic

Dosage & Admnistration

Shake before use. Adults and children 12 years of age and older: apply over affected areas not more than four times daily; massage as necessary. Children under 12 years of age: Consult physician.

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

Keep out of reach of children.

Inner Primary Container Label Front and Back

NDC 82765-0043-1


Advanced Ingredient Data


Raw Label Data

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