Denticalm Massaging Roll On

Denticalm Massaging Roll On
SPL v2
SPL
SPL Set ID 414e6f6f-06bb-b470-e063-6294a90af390
Route
TOPICAL
Published
Effective Date 2024-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 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

Description

Menthol 2% Purpose: Topical Analgesic

Purpose

Purpose: Topical Analgesic


Medication Information

Purpose

Purpose: Topical Analgesic

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)

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.

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.

Outer Package

NDC 82765-0002-0

Active Ingredient

Menthol 2% Purpose: Topical Analgesic

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

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 82765-0002-1


Structured Label Content

Usage

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

Purpose

Purpose: Topical Analgesic

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.

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.

Outer Package

NDC 82765-0002-0

Active Ingredient

Menthol 2% Purpose: Topical Analgesic

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

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 82765-0002-1


Advanced Ingredient Data


Raw Label Data

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