72937-006-02

72937-006-02
SPL v6
SPL
SPL Set ID f03090fa-f7e6-f53a-e053-2a95a90aa819
Route
TOPICAL
Published
Effective Date 2023-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-09-22 Until 2027-01-03

Description

Camphor 2% Menthol 6%


Medication Information

Warnings and Precautions

For external use only. • Ask a doctor before use if you have redness over

affected area.

Description

Camphor 2% Menthol 6%

Uses:

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 or use with a heating pad

Avoid contact with eyes and mucous membranes

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

A transient burning sensation or redness may occur upon application but generally disappears in several days

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

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

Section 51727-6

Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 55105-1

Topical Analgesic

Section 55106-9

Camphor 2%

Menthol 6%

Section 60561-8

Store tightly closed in a dry place at controlled room temperature between 59°-86° F

(15°-30° C).

Directions:

Adults and Children over 12 years

• Apply a small amount on the affected area.• Massage in circular motion, let set for a

few seconds.• Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands

with soap and water after use.

Children under 12 years of age 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 injury, such as pain, swelling or blistering where the product was applied.

If Pregnant Or Breast – Feeding:

Ask a health professional before use.

Sunset Cooling Pain Relief Gel 2oz

Sunset Cooling Pain Relief Gel 4oz

Sunset Cooling Pain Relief Gel 8oz

Sunset Cooling Pain Relief Gel 16oz


Structured Label Content

Uses: (USES:)

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

Warnings and Precautions (34071-1)

For external use only. • Ask a doctor before use if you have redness over

affected area.

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 or use with a heating pad

Avoid contact with eyes and mucous membranes

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

A transient burning sensation or redness may occur upon application but generally disappears in several days

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

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

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Camphor 2%

Menthol 6%

Section 60561-8 (60561-8)

Store tightly closed in a dry place at controlled room temperature between 59°-86° F

(15°-30° C).

Directions: (DIRECTIONS:)

Adults and Children over 12 years

• Apply a small amount on the affected area.• Massage in circular motion, let set for a

few seconds.• Repeat as necessary, but no more than 3 to 4 times daily. • Wash hands

with soap and water after use.

Children under 12 years of age 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 injury, such as pain, swelling or blistering where the product was applied.

If Pregnant Or Breast – Feeding: (IF PREGNANT OR BREAST – FEEDING:)

Ask a health professional before use.

Sunset Cooling Pain Relief Gel 2oz (SUNSET - COOLING PAIN RELIEF GEL 2oz)

Sunset Cooling Pain Relief Gel 4oz (SUNSET - COOLING PAIN RELIEF GEL 4oz)

Sunset Cooling Pain Relief Gel 8oz (SUNSET - COOLING PAIN RELIEF GEL 8oz)

Sunset Cooling Pain Relief Gel 16oz (SUNSET - COOLING PAIN RELIEF GEL 16oz)


Advanced Ingredient Data


Raw Label Data

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