Capsaicin Cream

Drug Facts

Composition & Product

Active Ingredients

Capsaicin (0.025 g)

Inactive Ingredients

Water Arnica Montana Flower Indian Frankincense Cetostearyl Alcohol Chondroitin Sulfate (bovine) Ethylhexylglycerin Glucosamine Sulfate Glycerin Glyceryl Monostearate C13-14 Isoparaffin Isostearyl Palmitate Laureth-7 Dimethyl Sulfone Peg-100 Stearate Phenoxyethanol Propylene Glycol Stearic Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-10-01

Medication Information

Purpose

External analgesic

Description

CAPSAICIN – Capsaicin 0.025% 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. ---------- Capsaicin 0.025% Cream Drug Facts

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• 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

Uses

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

• simple backache

• arthritis

• strains

• sprains

Section 42229-5

CAPSAICIN – Capsaicin 0.025% 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.

----------

Capsaicin 0.025% Cream

Drug Facts

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

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

Do Not Use

• On wounds or damaged skin

• If you are allergic to capsicum or chili peppers

Stop Use and As

• Condition worsens or does not improve after regular use

• Severe burning persists or blistering occurs

Active Ingredient

Capsaicin 0.025%

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

Capsaicin 0.025 % cream

NDC 50488-1025-1

120 grams

Capsaicin 0.025% cream

NDC 50488-1025-5

50 grams

Capsaicin 0.025% cream

NDC 50488-1025-2

25 grams

Alexso, Inc

Principal Display Panel

NDC 50488-1025-1

Capsaicin 0.025% Cream

120 grams

Keep Out of Reach of Children.

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

Structured Label Content

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• 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

Uses

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

• simple backache

• arthritis

• strains

• sprains

Section 42229-5 (42229-5)

CAPSAICIN – Capsaicin 0.025% 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.

----------

Capsaicin 0.025% Cream

Drug Facts

Purpose

External analgesic

Warnings

For external use only

Read all warnings and directions before use. Test first on small area of skin.

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

Do Not Use (Do not use)

• On wounds or damaged skin

• If you are allergic to capsicum or chili peppers

Stop Use and As (Stop use and as)

• Condition worsens or does not improve after regular use

• Severe burning persists or blistering occurs

Active Ingredient (Active ingredient)

Capsaicin 0.025%

Other Information (Other information)

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

Inactive Ingredients (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

Capsaicin 0.025 % cream

NDC 50488-1025-1

120 grams

Capsaicin 0.025% cream

NDC 50488-1025-5

50 grams

Capsaicin 0.025% cream

NDC 50488-1025-2

25 grams

Alexso, Inc

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 50488-1025-1

Capsaicin 0.025% Cream

120 grams

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information