Capsaicin 0.035% Cream

Manufacturer
Puretekcorp
Effective date
2025-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:13

Label at a glance#

ProductCapsaicin 0.035% Cream
Active ingredientCAPSAICIN
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...

Storage and handling

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

Label contents#

Full prescribing information#

Active ingridient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.035%

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 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

OTC - WHEN USING 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 - STOP USE SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING 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.

Capsaicin 0.035% Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577395capsaicin 0.035 % Topical CreamPSN1
577395capsaicin 0.35 MG/ML Topical CreamSCD1
577395capsaicin 0.035 % Topical CreamSY1

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
59088-246-08Capsaicin 0.035% Cream120 g in 1 TUBECREAM1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-246-08GM - Gram59088-2469babf7a1-115f-4b46-8a1d-8c33a1b6f74c12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-24659088-246-08

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 0.035% CreamCAPSAICIN 0.035% CREAMPuretekcorp3cbc73b6-8c58-8f23-e063-6394a90a71a32025-08-20WarningsExact identifier
ndc (package): 59088-246-08
ndc (product): 59088-246
ndc11 (package): 59088024608
spl id: 3cbc73b6-8c59-8f23-e063-6394a90a71a3
spl set id: 3cbc73b6-8c58-8f23-e063-6394a90a71a3

Reported adverse events (FAERS/openFDA)#

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