Csi, Menthol, Pain Relief Gel-roll On, 2.5 Fl. Oz / 74 Ml, Gel, Bottle

Csi, Menthol, Pain Relief Gel-roll On, 2.5 Fl. Oz / 74 Ml, Gel, Bottle
SPL v2
SPL
SPL Set ID f0bc2a14-6bda-428c-e053-2995a90a4ced
Route
TOPICAL
Published
Effective Date 2022-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.04 g)
Inactive Ingredients
Alcohol 95% Trolamine Water Silicon Dioxide Ilex Paraguariensis Leaf Isopropyl Myristate .alpha.-tocopherol, D- Aloe Vera Leaf Glycerin Fd&c Yellow No. 5 Fd&c Blue No. 1 Green Tea Leaf Carbomer Homopolymer, Unspecified Type Frankincense Arnica Montana Flower Camphor (synthetic)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-28

Description

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Section 50570-1

• Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Do not use with heating pad or device

Section 51945-4

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Directions

Adults and children 12 years of age and older :

Rub a thin film over affected areas not more than 4 times daily; message not necessary

Children under 12 years of age : Consult physician

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Questions Or Comments

86-21-31166566

When Using This Product

Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place

Stop Use and Ask A Doctor If

Condition worsens or if symptoms persist for more than 7 days, or clear up and reoccur

If Pregnant Or Breast Feeding

Ask a health professional before use

Keep Out of Reach of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have

Sensitive skin


Structured Label Content

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Section 50570-1 (50570-1)

• Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Do not use with heating pad or device

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For external use only

Flammable

Keep away from excessive heat or open flame

Directions

Adults and children 12 years of age and older :

Rub a thin film over affected areas not more than 4 times daily; message not necessary

Children under 12 years of age : Consult physician

Active Ingredient

Menthol 4.0% w/w ...... Purpose: Topical Analgesic

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Questions Or Comments (Questions or Comments)

86-21-31166566

When Using This Product (When using this product)

Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place

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

Condition worsens or if symptoms persist for more than 7 days, or clear up and reoccur

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

Ask a health professional before use

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

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Sensitive skin


Advanced Ingredient Data


Raw Label Data

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