83037-105-04

83037-105-04
SPL v1
SPL
SPL Set ID 37d022b3-b4b4-9fba-e063-6294a90a7122
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (9 g)
Inactive Ingredients
Alcohol Propylene Glycol Glycerin Aloe Barbadensis Leaf Juice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-30

Description

Menthol 10.5%


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

Menthol 10.5%

Use

For temporary relief of minor aches and pains of muscles and 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.

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, Glycerin, Propylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Juice.

Section 53414-9

If pregnant or breast – feeding

Ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 10.5%

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.

Other Information

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

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.

Dzul Fast Freeze Instant Pain Relief


Structured Label Content

Use (USE)

For temporary relief of minor aches and pains of muscles and 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)

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, Glycerin, Propylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Juice.

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)

Menthol 10.5%

Flammable

Keep away from fire or flame.

Directions (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.

Other Information (OTHER INFORMATION)

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

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.

Dzul Fast Freeze Instant Pain Relief (DZUL FAST FREEZE INSTANT PAIN RELIEF)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)