SPL v1
SPL
SPL Set ID b2b2de93-d957-43d7-a2a8-b46bcaea1f0d
Route
TOPICAL
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.035 g)
Inactive Ingredients
Water Arnica Montana Flower Boswellia Serrata Whole Cetearyl Olivate Cetyl Alcohol Dimethyl Sulfone Ethylhexylglycerin Glycerin Glyceryl Monostearate Hemp Peg-100 Monostearate Phenoxyethanol Polysorbate 20 Resveratrol Sodium Laurylglucosides Hydroxypropylsulfonate Sorbitan Olivate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-05

Description

Capsaicin 0.035%                                      External Analgesic

Purpose

Capsaicin 0.035%                                      External Analgesic


Medication Information

Purpose

Capsaicin 0.035%                                      External Analgesic

Description

Capsaicin 0.035%                                      External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains, 
  • sprains
Section 50565-1

Section 55105-1

Warnings

For external use only

Read all warnings and directions before use.

Test first on small area of skin.

Do not use

• On wounds or damaged skin.

• If you are allergic to capsicum or chili peppers.

When using this product

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes

• Do not tightly wrap or bandage the treated area

• Do not apply heat to the treated area immediately before or after use.

Stop use and ask a doctor if

• Conditions worsens or does not improve after regular use.

• Severe burning persists o blistering occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

 Adults and children 18 years of age and older:

  • Apply a thin film of cream to affected area and gently rub in until fully absorbed.
  • Unless treating hands, wash hands thoroughly with soap and water immediately after application.
  • For best results, apply 3 to 4 times daily.
  • Children under 18 years: ask a doctor

Product Label

Other Information
  • Store at room temperature 15°-30°C (59°-86°F).
  • Protect product from excessive moisture.
Inactive Ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid

Active Ingredient                                     purpose

Capsaicin 0.035%                                      External Analgesic


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains, 
  • sprains
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only

Read all warnings and directions before use.

Test first on small area of skin.

Do not use

• On wounds or damaged skin.

• If you are allergic to capsicum or chili peppers.

When using this product

• You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

• Avoid contact with the eyes, lips, nose and mucous membranes

• Do not tightly wrap or bandage the treated area

• Do not apply heat to the treated area immediately before or after use.

Stop use and ask a doctor if

• Conditions worsens or does not improve after regular use.

• Severe burning persists o blistering occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

 Adults and children 18 years of age and older:

  • Apply a thin film of cream to affected area and gently rub in until fully absorbed.
  • Unless treating hands, wash hands thoroughly with soap and water immediately after application.
  • For best results, apply 3 to 4 times daily.
  • Children under 18 years: ask a doctor

Product Label (Product label)

Other Information
  • Store at room temperature 15°-30°C (59°-86°F).
  • Protect product from excessive moisture.
Inactive Ingredients (Inactive ingredients)

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid

Active Ingredient                                     purpose (Active Ingredient                                     Purpose)

Capsaicin 0.035%                                      External Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)