87083-007

87083-007
SPL v1
SPL
SPL Set ID 41bd0769-6ba0-d0d5-e063-6294a90af7c9
Route
TOPICAL
Published
Effective Date 2025-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (30 g) Capsaicin (0.025 g) Camphor (natural) (5 g)
Inactive Ingredients
Carbomer 940 Glyceryl Monostearate Cetostearyl Alcohol Sodium Hydroxide Peg-60 Stearate Water Phenoxyethanol Edetate Calcium Disodium Allantoin Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-22

Description

Methyl salicylate 30% Capsaicin 0.025% Camphor 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Methyl salicylate 30% Capsaicin 0.025% Camphor 5%

Use

Temporarily relieves muscle and stiffness due to:

■minor injuries

■overexertion

■falls reduces symptoms of bruising such as:

■pain■swelling■discoloration

Stop Use

Condition persists for more than 3 days or worsens osymptoms clear up and occur again within a few days.

Warnings

For external use only.

Ask Doctor

Condition persists for more than 3 days or worsens osymptoms clear up and occur again within a few days.

Directions

Apply a thin layer of cream to the affected area as soon as possible after minor injury.Repeat 3 times a day or as needed. if heat or ice is applied, wait 5 minutes before applying cream.Children under 2 years of age: do not use, consult a physician or doctor.

Do Not Use

you are allergic to cream or to any of this product's inactive ingredients.

When Using

Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin. Use only directed dryness or irritation may occurdo not tightly wrap or bandage the treated areado not apply heat or ice to treated area immediately before or after use.

Active Ingredient

Methyl salicylate 30%

Capsaicin 0.025%

Camphor 5%

Inactive Ingredients

PEG-100 stearate, Glycerol stearate, Cetyl stearol, water, Chlorphenylate, Phenoxyethanol, EDTA-2NA, Allantoin, Polydimethylsiloxane, Carbomer 940, Sodium hydroxide.

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

Temporarily relieves muscle and stiffness due to:

■minor injuries

■overexertion

■falls reduces symptoms of bruising such as:

■pain■swelling■discoloration

Purpose

Topical analgesic

Stop Use

Condition persists for more than 3 days or worsens osymptoms clear up and occur again within a few days.

Warnings

For external use only.

Ask Doctor

Condition persists for more than 3 days or worsens osymptoms clear up and occur again within a few days.

Directions

Apply a thin layer of cream to the affected area as soon as possible after minor injury.Repeat 3 times a day or as needed. if heat or ice is applied, wait 5 minutes before applying cream.Children under 2 years of age: do not use, consult a physician or doctor.

Do Not Use (Do not use)

you are allergic to cream or to any of this product's inactive ingredients.

When Using

Avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin. Use only directed dryness or irritation may occurdo not tightly wrap or bandage the treated areado not apply heat or ice to treated area immediately before or after use.

Active Ingredient

Methyl salicylate 30%

Capsaicin 0.025%

Camphor 5%

Inactive Ingredients (Inactive ingredients)

PEG-100 stearate, Glycerol stearate, Cetyl stearol, water, Chlorphenylate, Phenoxyethanol, EDTA-2NA, Allantoin, Polydimethylsiloxane, Carbomer 940, Sodium hydroxide.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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