49283-579-20

49283-579-20
SPL v3
SPL
SPL Set ID 4a05f02e-e882-2cb2-e063-6394a90ad328
Route
TOPICAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (18 g)
Inactive Ingredients
Glyceryl Monostearate Cetyl Alcohol Glycereth-26 Trideceth-6 Caprylyl Glycol Phenoxyethanol Comfrey Leaf Cannabis Sativa Seed Oil Water Hyaluronate Sodium Amino Acids, Wheat Panthenol Hydroxyproline Hexylene Glycol Stearic Acid Dimethicone 1000 Stearyl Alcohol Trolamine Sodium Pyrrolidone Carboxylate Mineral Oil Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-29

Description

Methyl Salicylate 18% Menthol 10%


Medication Information

Warnings and Precautions

For external use only. · Ask a doctor before use if you have redness over affected area

Description

Methyl Salicylate 18% Menthol 10%

Use

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

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

Section 55105-1

Topical Analgesic.

Section 55106-9

Methyl Salicylate 18%

Menthol 10%

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.

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

If Pregnant Or Breast Feeding

Ask a health professional before use.

Generic Label Ultra Strenght Pain Relief Cream


Structured Label Content

Use

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

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

Section 55105-1 (55105-1)

Topical Analgesic.

Section 55106-9 (55106-9)

Methyl Salicylate 18%

Menthol 10%

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.

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 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.

Generic Label Ultra Strenght Pain Relief Cream (GENERIC LABEL - ULTRA STRENGHT PAIN RELIEF CREAM)


Advanced Ingredient Data


Raw Label Data

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