Sunset - Cooling Pain Relief Gel 4oz Tube Limited Edition

Sunset - Cooling Pain Relief Gel 4oz Tube Limited Edition
SPL v2
SPL
SPL Set ID 10d0a0ac-aaad-7750-e063-6294a90a30fd
Route
TOPICAL
Published
Effective Date 2024-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


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.

Indications and Usage

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

Dosage and Administration

Adults and Children over 12 years Apply a small amount on 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. Children under 12 years of age: do not use, consult a doctor.

Description

Camphor 2% Menthol 6%

Section 50565-1

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

Section 50566-9

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.

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 51945-4

cooling 2000

Section 53414-9

Ask a health professional before use.

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).


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adults and Children over 12 years Apply a small amount on 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. Children under 12 years of age: do not use, consult a doctor.

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 50566-9 (50566-9)

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.

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 51945-4 (51945-4)

cooling 2000

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%

Section 60561-8 (60561-8)

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


Raw Label Data

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