Capsaicin 0.05% Cream

Manufacturer
Puretek Corporation
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:31

Label at a glance#

ProductCapsaicin 0.05% Cream
Active ingredientCAPSICUM OLEORESIN
Label structure8 sections

Indications and uses

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

Dosage and administration

• 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 applicatio...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsicum Oleoresin (Containing Capsaicin 0.05%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

When using this product

SPL UNCLASSIFIED SECTION

• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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 INGREDIENT SECTION

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.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200083capsaicin 0.05 % Topical CreamPSN2
200083capsaicin 0.5 MG/ML Topical CreamSCD2
200083capsaicin 0.05 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-223-08Capsaicin 0.05% Cream120 g in 1 BOTTLE, PUMPCREAM1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-223CAPSAICIN 0.05% CREAM (CAPSAICIN 0.05%) CREAM [PURETEK CORPORATION]2Current NDC, 1 package rows20250305_2cf17a28-711f-77bd-e063-6394a90a7061.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-223-08GM - Gram59088-223860de7b8-ceed-4587-89f5-a397cb9f5af612025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-22359088-223-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Capsaicin 0.05% CreamCAPSAICIN 0.05%Puretek Corporation2cf17a28-711f-77bd-e063-6394a90a70612025-02-28WarningsExact identifier
ndc (package): 59088-223-08
ndc (product): 59088-223
ndc11 (package): 59088022308
spl id: 2f3d2563-85c8-d5a3-e063-6294a90a6d3c
spl set id: 2cf17a28-711f-77bd-e063-6394a90a7061

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.