1d68e805-b8da-aa0d-e063-6394a90a2e3c

SPL v1
SPL
SPL Set ID 1d68e805-b8da-aa0d-e063-6394a90a2e3c
Route
topical
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (0.04 g)
Inactive Ingredients
water silicon dioxide ilex paraguariensis leaf .alpha.-tocopherol, d- glycerin green tea leaf carbomer homopolymer, unspecified type arnica montana flower fd&c blue no. 1 isopropyl myristate trolamine aloe vera leaf frankincense camphor (synthetic) alcohol 95% fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-17

Purpose

Topical Analgesic

Description

Menthol 4% ...... Purpose: Topical Analgesic


Medication Information

Warnings

For external use only

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

Purpose

Topical Analgesic

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.

Wash hands after use with cool water.

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, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water

Description

Menthol 4% ...... Purpose: Topical Analgesic

Dosage

74 mL in 1 BOTTLE

Section 51945-4

Do Not Use

• on wounds or damaged skin

• with a heating pad or device

• with other ointments, creams, sprays, or liniments

• if you are allergic to any ingredients of this product

Stop Use ... If

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

Active Ingredient

Menthol 4% ...... Purpose: Topical Analgesic

... Ask A Doctor If

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

Questions Or Comments:

cs@medhomegroup,com

When Using This Product

• use only as directed

• avoid contact with the eyes, mucous membranes, or rashes

• do not bandage tightly

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out of Reach of Children.

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.

Purpose

Topical Analgesic

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.

Wash hands after use with cool water.

Inactive Ingredients (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, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, Water

Dosage

74 mL in 1 BOTTLE

Section 51945-4 (51945-4)

Do Not Use (Do not use)

• on wounds or damaged skin

• with a heating pad or device

• with other ointments, creams, sprays, or liniments

• if you are allergic to any ingredients of this product

Stop Use ... If (Stop use ... if)

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

Active Ingredient (Active ingredient)

Menthol 4% ...... Purpose: Topical Analgesic

... Ask A Doctor If (... ask a doctor if)

• skin reactions such as redness, swelling, blistering or other discomfort occur

• symptoms persist for more than 7 days

Questions Or Comments: (Questions or Comments:)

cs@medhomegroup,com

When Using This Product (When using this product)

• use only as directed

• avoid contact with the eyes, mucous membranes, or rashes

• do not bandage tightly

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 swallowed accidentally, get medical help or contact with Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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