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FDA LABEL GENERIC: Capsaicin MFR: Alexso, Inc

Capsaicin 0.1 % Topical Cream

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

Capsaicin 0.1%

External analgesic

INDICATIONS AND USAGE

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.

• On wounds or damaged skin

• If you are allergic to capsicum or chili peppers

• 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

• Condition worsens or does not improve after regular use

• Severe burning persists or blistering occurs

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

DOSAGE AND ADMINISTRATION

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

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

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

ASK A DOCTOR

Capsaicin 0.1 %   C ream

NDC 50488-1060-6

6 0 grams

Alexso, Inc