Sunset - Heating Pain Relief Cream 4 Oz Tube Limited Edition

Sunset - Heating Pain Relief Cream 4 Oz Tube Limited Edition
SPL v2
SPL
SPL Set ID 10d05b4a-f97d-4b99-e063-6294a90a8aa7
Route
TOPICAL
Published
Effective Date 2024-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Menthol 10% Methyl Salicylate 18%


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, 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: do not use, consult a doctor

Description

Menthol 10% Methyl Salicylate 18%

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 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

Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD & C Yellow No.6 (CI 15985).

Section 51945-4

heating 2000

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic.

Section 55106-9

Menthol 10% Methyl Salicylate 18%

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, 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: 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 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)

Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD & C Yellow No.6 (CI 15985).

Section 51945-4 (51945-4)

heating 2000

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic.

Section 55106-9 (55106-9)

Menthol 10% Methyl Salicylate 18%

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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