Capsaicin 0.035% Cream CAPSAICIN 0.035% PURETEKCORP FDA Approved Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains.
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Substance Capsaicin
Route
TOPICAL
Applications
M017
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingridient Capsaicin 0.035%
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.
Strengths
0.035 %
Treats Conditions
Uses For The Temporary Relief Of Minor Aches And Pains Of Muscles And Joints Associated With Simple Backache Arthritis Strains And Sprains

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
S07O44R1ZM
Packaging

Capsaicin 0.035% Cream Label

Package Descriptions
  • Capsaicin 0.035% Cream Label

Overview

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

Indications & Usage

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

Dosage & Administration

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.

Warnings & Precautions
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.
Purpose

Purpose Topical Analgesic

When Using

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.

Stop Use & Ask a Doctor

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.

Keep Out of Reach of Children

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.

Storage & Handling

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.