Capsaicin 0.035% Cream
Capsaicin 0.035% Cream 59088-246
3cbc73b6-8c58-8f23-e063-6394a90a71a3
HUMAN OTC DRUG LABEL
Aug 20, 2025
Puretekcorp
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Capsaicin 0.035% Cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (32)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Capsaicin 0.035% Cream
INDICATIONS & USAGE SECTION
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains.
OTC - ACTIVE INGREDIENT SECTION
Active ingridient
Capsaicin 0.035%
OTC - PURPOSE SECTION
Purpose
Topical Analgesic
WARNINGS SECTION
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.
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.
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.
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.
DOSAGE & ADMINISTRATION SECTION
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.
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
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.