Capsaicin 0.035% Cream 59088-246

Capsaicin 0.035% Cream 59088-246
SPL v1
SPL
SPL Set ID 3cbc73b6-8c58-8f23-e063-6394a90a71a3
Route
TOPICAL
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.35 mg)
Inactive Ingredients
Bisabolol C12-15 Alkyl Benzoate .alpha.-tocopherol Acetate, Dl- Isopropyl Myristate Lavandula Angustifolia (lavender) Oil Sodium Ascorbyl Phosphate Sodium Hyaluronate Maltodextrin Ginger Phenoxyethanol Aluminum Starch Octenylsuccinate Pyridoxine Hcl Dimethicone C13-14 Isoparaffin Carthamus Tinctorius (safflower) Oleosomes Calendula Officinalis Flower Silica Aloe Barbadensis Leaf Juice Aqua Glycerin Calcium Pantothenate Ginkgo Biloba Leaf Arnica Montana Flower Cetearyl Alcohol Peg-100 Stearate Chamomile Glyceryl Stearate Myristyl Myristate Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Niacinamide Laureth-7

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-20

Description

Capsaicin 0.035%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.035%

Uses

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

Section 50565-1

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.

Section 50566-9

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Section 50569-3

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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 sensation.

• 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 Ingridient

Capsaicin 0.035%

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.

Capsaicin 0.035% Cream

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.

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Section 50569-3 (50569-3)

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

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 sensation.

• 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 Ingridient (Active ingridient)

Capsaicin 0.035%

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.

Capsaicin 0.035% Cream

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


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