Capsaicin 0.05% Cream

Capsaicin 0.05% Cream
SPL v2
SPL
SPL Set ID 2cf17a28-711f-77bd-e063-6394a90a7061
Route
TOPICAL
Published
Effective Date 2025-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Calendula Officinalis Flower Cetearyl Alcohol Phenoxyethanol Silica Arnica Montana Flower Carthamus Tinctorius (safflower) Oleosomes Myristyl Myristate Niacinamide Glycerin Peg-100 Stearate Aluminum Starch Octenylsuccinate Ginger Sodium Hyaluronate Bisabolol Maltodextrin Aqua Ginkgo Biloba Leaf Isopropyl Myristate Laureth-7 Lavandula Angustifolia (lavender) Oil C13-14 Isoparaffin Calcium Pantothenate Sodium Ascorbyl Phosphate Pyridoxine Hcl C12-15 Alkyl Benzoate Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Aloe Vera Leaf Chamomile Dimethicone .alpha.-tocopherol Acetate, Dl- Glyceryl Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-30

Description

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Oleoresin (Containing Capsaicin 0.05%)

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.

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 burning sentation.

• Do not use with 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.

Active Ingredient

Capsicum Oleoresin (Containing Capsaicin 0.05%)

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.

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.

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 burning sentation.

• Do not use with 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.

Active Ingredient (Active ingredient)

Capsicum Oleoresin (Containing Capsaicin 0.05%)

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.

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.

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.


Advanced Ingredient Data


Raw Label Data

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