Capsaicin Cream 0.1%

Manufacturer
AvPAK
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:12

Label at a glance#

ProductCapsaicin
Active ingredientCAPSAICIN
Label structure9 sections

Storage and handling

Other Information: store at room temperature 15° - 30°C (59° - 86°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Capsaicin 0.1%

OTC - PURPOSE SECTION

Purpose: Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

Warnings: For external use only.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad

When using this produce:

  • you may experience a burning sensation The intensity of this reaction varies among individuals and may be severe. With regular use, the sensation generally disappears after several days.
  • avoid contact with the eyes, lips, nose and mucous membranes
  • do not tightly wrap or bandage the treatement area
  • do not apply heat, or direct sunlight to the treated area immediately before or after use

Stop use and ask a doctor if:

  • condition worsens or does not improve after regular use
  • severe burning persists
  • redness or blistering occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions – Adults and children 18 years of age and older

  • apply a thin film of cream to affected area and gently rub in until fully absorbed
  • unless treating hands, wash hands thoroughly with soap and water immediately after application
  • for best results, apply 3 to 4 times daily


Children under 18 years: ask a doctor.

STORAGE AND HANDLING SECTION

Other Information:store at room temperature 15° - 30°C (59° - 86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

SPL UNCLASSIFIED SECTION

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5656

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN4
646333capsaicin 1 MG/ML Topical CreamSCD4
646333capsaicin 0.1 % Topical CreamSY4

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
50268-197-56Capsaicin1 in 1 CARTONCREAM14
50268-197-56Capsaicin56.6 g in 1 TUBECREAM56.64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-197-56GM - Gram50268-197445b6307-5000-48d2-991b-f541451c7d5a12023-01-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-19750268-197-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
CapsaicinCAPSAICINAvPAKef5b0db6-8f0a-4f8e-e053-2995a90a22b72026-01-08WarningsExact identifier
ndc (package): 50268-197-56
ndc (product): 50268-197
ndc11 (package): 50268019756
spl id: 47e2f93a-977a-7137-e063-6394a90afbf3
spl set id: ef5b0db6-8f0a-4f8e-e053-2995a90a22b7

Reported adverse events (FAERS/openFDA)#

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