Capsaicin 0.025% Cream

Capsaicin 0.025% Cream
SPL v1
SPL
SPL Set ID 28f00df0-c416-f17b-e063-6294a90a5570
Route
TOPICAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Ethyl Menthane Carboxamide Glycerin Mentha Piperita (peppermint) Oil Rosmarinus Officinalis (rosemary) Leaf Oil Triethanolamine Lauryl Laurate Ethylhexylglycerin Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Alcohol Menthyl Lactate, (-)- Aloe Barbadensis Leaf Juice Aqua Arnica Montana Flower Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Linum Usitatissimum (linseed) Seed Oil Methyl Diisopropyl Propionamide Ppg-2 Hydroxyethyl Cocamide Hydroxyethyl Behenamidopropyl Dimonium Chloride Euterpe Oleracea Fruit Oil Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-02

Description

Capsicum Oleoresin (Containing Capsaicin 0.025%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Oleoresin (Containing Capsaicin 0.025%)

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Label

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Section 50565-1

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. if swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Purpose:

Topical Analgesic

Warnings:

For external use only

• This is not a face cream. Do not apply to the face.

• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

• Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.

• Do not bandage tightly.

• Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water,

perspiration or open pores can intensify the impact of this product and cause a burning sensation.

• Do not use with a heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious

burns.

Directions:

• Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.

• Before using on children under 18 years of age consult a physician.

• Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.

• Gently massage into the skin until fully absorbed.

• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Other Information

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Active Ingredients:

Capsicum Oleoresin (Containing Capsaicin 0.025%)

Inactive Ingredient

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.

When Using This Product

• Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.


Structured Label Content

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Label

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Section 50565-1 (50565-1)

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. if swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Purpose:

Topical Analgesic

Warnings:

For external use only

• This is not a face cream. Do not apply to the face.

• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.

• Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.

• Do not bandage tightly.

• Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water,

perspiration or open pores can intensify the impact of this product and cause a burning sensation.

• Do not use with a heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious

burns.

Directions:

• Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.

• Before using on children under 18 years of age consult a physician.

• Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.

• Gently massage into the skin until fully absorbed.

• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Other Information (Other information)

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Active Ingredients:

Capsicum Oleoresin (Containing Capsaicin 0.025%)

Inactive Ingredient (Inactive ingredient)

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Ethyl Alcohol, Ethyl Menthane Carboxamide, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.

When Using This Product (When using this product)

• Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.


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