73647-602-04

73647-602-04
SPL v3
SPL
SPL Set ID f65327b3-9c97-58f3-e053-2995a90a3f55
Route
TOPICAL
Published
Effective Date 2024-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6 g) Camphor (synthetic) (2 g)
Inactive Ingredients
Carbomer 940 Water Sodium Hydroxide Mentha Arvensis Leaf Oil Rosemary Oil Thyme Oil Tea Tree Oil Benzyl Alcohol Sorbic Acid Fd&c Blue No. 1 Fd&c Yellow No. 5 Alcohol Propylene Glycol Salicylic Acid Glycerin Polysorbate 20 Cannabidiol Limonene, (+)-

Identifiers & Packaging

Pill Appearance
Color: turquoise
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-03-14 Until 2026-05-08

Description

Camphor 2% Menthol 6%


Medication Information

Warnings and Precautions

For external use only.

Description

Camphor 2% Menthol 6%

Use

Aid for temporary local relief of minor pain in muscles or joints.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

Use only as directed.

Do not bandage tightly

Do not use with heating pad, pack, wrap hot water bottle or any heating element.

Avoid contact with eyes.

Do not apply to wounds or damaged, broken, or irritated skin.

Do not expose the area treated with product to heat or direct sunlight.

Section 50569-3

Ask a doctore before use if you have redness over affected area

Section 51727-6

Water (Aqua), Propylene Glycol, Alcohol Denat, Polysorbate 20, Mentha Piperita (Peppermint) Oil, Cannabidiol, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Carbomer, Sodium Hydroxide, Benzyl Alcohol, Salicylic Acid, Glycerin, Sorbic Acid, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140), Limonene.

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor 2%

Menthol 6%

Directions:

Adults over 21 years:

Apply a small amount to the affected area.

Massage in circular motion until absorbed.

Repeat as needed, but no more than 3 to 4 times per day.

Wash hands with soap and water after use.

Other Information

Store tightly closed in a dry place at controlled temperature between 59°-86° F (15°-30° C).

This product is intended only for use by healthy adults aged 21 years & older.

Stop Use and Ask A Doctor If:

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

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Structured Label Content

Use (USE)

Aid for temporary local relief of minor pain in muscles or joints.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

Use only as directed.

Do not bandage tightly

Do not use with heating pad, pack, wrap hot water bottle or any heating element.

Avoid contact with eyes.

Do not apply to wounds or damaged, broken, or irritated skin.

Do not expose the area treated with product to heat or direct sunlight.

Section 50569-3 (50569-3)

Ask a doctore before use if you have redness over affected area

Section 51727-6 (51727-6)

Water (Aqua), Propylene Glycol, Alcohol Denat, Polysorbate 20, Mentha Piperita (Peppermint) Oil, Cannabidiol, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Carbomer, Sodium Hydroxide, Benzyl Alcohol, Salicylic Acid, Glycerin, Sorbic Acid, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140), Limonene.

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor 2%

Menthol 6%

Directions: (DIRECTIONS:)

Adults over 21 years:

Apply a small amount to the affected area.

Massage in circular motion until absorbed.

Repeat as needed, but no more than 3 to 4 times per day.

Wash hands with soap and water after use.

Other Information (OTHER INFORMATION)

Store tightly closed in a dry place at controlled temperature between 59°-86° F (15°-30° C).

This product is intended only for use by healthy adults aged 21 years & older.

Stop Use and Ask A Doctor If: (STOP USE AND ASK A DOCTOR IF:)

Condition worsens.

Redness is present.

Irritation develops.

Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs injury, such as pain, swelling or blistering where the product was applied.

Just Cbd Ultra Relief Gel +1000 (JUST CBD ULTRA RELIEF GEL +1000)

Just Cbd Ultra Relief Gel +5000 (JUST CBD ULTRA RELIEF GEL +5000)


Advanced Ingredient Data


Raw Label Data

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