Capsaicin Cream

SPL UNCLASSIFIED SECTION

CAPSAICIN – Capsaicin 0.1% Cream

Alexso, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Capsaicin 0.1% Cream

Drug Facts

Active ingredient

Capsaicin 0.1%

Purpose

External analgesic

Uses

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

• simple backache

• arthritis

• strains

• sprains

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

• Condition worsens or does not improve after regular use

• Severe burning persists or 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

Other information

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine