72524-900-02

72524-900-02
SPL v2
SPL
SPL Set ID 30a1c6b7-e37e-32c2-e063-6394a90aa354
Route
TOPICAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (5.3 g) Menthol (3.6 g)
Inactive Ingredients
Water Salicylic Acid Sorbic Acid Benzyl Alcohol Alcohol Glycerin Aloe Vera Leaf Juice Cannabidiol Cannabis Sativa Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-03-28 Until 2027-06-11

Description

Camphor 6% Menthol 4%


Medication Information

Warnings and Precautions

For external use only.

Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Description

Camphor 6% Menthol 4%

Use

For temporary relief of minor pains on muscles or joints.

Section 50565-1

Keep out of reach of children

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

Section 50567-7

Use only as directed.

Do not bandage tightly.

Avoid contact with eyes and mucous membranes.

If you experience an allergic reaction, discontinue use, and consult a doctor.

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

Section 51727-6

Alcohol Denat, Water (Aqua), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Cannabidiol, Cannabis Sativa (Hemp) Seed Oil, Benzyl Alcohol, Sorbic Acid, Salicylic Acid.

Section 53413-1

Call +1-787-421-6423

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor 6%

Menthol 4%

Section 60561-8

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

Flammable

Keep away from fire or flame.

Directions

Adults and Children over 12 years of age

Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

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 of injury, such as pain, swelling or blistering where the product was applied.

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Structured Label Content

Use

For temporary relief of minor pains on muscles or joints.

Warnings and Precautions (34071-1)

For external use only.

Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Section 50565-1 (50565-1)

Keep out of reach of children

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.

Avoid contact with eyes and mucous membranes.

If you experience an allergic reaction, discontinue use, and consult a doctor.

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

Section 51727-6 (51727-6)

Alcohol Denat, Water (Aqua), Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Cannabidiol, Cannabis Sativa (Hemp) Seed Oil, Benzyl Alcohol, Sorbic Acid, Salicylic Acid.

Section 53413-1 (53413-1)

Call +1-787-421-6423

Section 53414-9 (53414-9)

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor 6%

Menthol 4%

Section 60561-8 (60561-8)

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

Flammable

Keep away from fire or flame.

Directions

Adults and Children over 12 years of age

Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

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 of injury, such as pain, swelling or blistering where the product was applied.

Ay Bendito Cbd Oil Spray 2 Fl Oz (AY BENDITO CBD OIL SPRAY 2 FL OZ)

Ay Bendito Cbd Oil Spray 4 Fl Oz (AY BENDITO CBD OIL SPRAY 4 FL OZ)


Advanced Ingredient Data


Raw Label Data

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