Capsaicin Cream 0.1%

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2024-06-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:57

Label at a glance#

ProductCapsaicin
Active ingredientCAPSAICIN
Label structure12 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains sprains

Dosage and administration

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

Store at room temperature 15°-30°F (59°-86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Warnings

WARNINGS SECTION

For external use only:Read all warnings and directions before use. Test first on small area of skin.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • do not use with heating pad or expose area to sunlight

When using this product:

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

Stop Use and Ask Doctor

OTC - STOP USE SECTION

Stope Use and Ask Doctor if:

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

Keep Out of the Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • arthritis
  • strains
  • sprains

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Questions? Comments?

1-855-361-3993

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°F (59°-86°F)

SPL UNCLASSIFIED SECTION

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
646333capsaicin 0.1 % Topical CreamPSN1
646333capsaicin 1 MG/ML Topical CreamSCD1
646333capsaicin 0.1 % 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
76420-753-42Capsaicin42.5 g in 1 TUBECREAM42.51
76420-753-42Capsaicin1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-753CAPSAICIN CREAM [ASCLEMED USA, INC.]1Current NDC, 2 package rows20240622_97d506bd-3215-4e2e-9914-af1c174dd4ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-198-42GM - Gram50268-198c4839838-8193-42aa-ab25-17fdf75ae14012023-01-09

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
76420-75376420-753-42
50268-198

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CapsaicinCAPSAICINAvPAKef5bb0fa-afc2-62d7-e053-2a95a90a37f42026-01-08WarningsExact identifier
ndc (product): 50268-198
CapsaicinCAPSAICINAsclemed USA, Inc.97d506bd-3215-4e2e-9914-af1c174dd4ab2024-06-20WarningsExact identifier
ndc (package): 76420-753-42
ndc (product): 76420-753
ndc11 (package): 76420075342
spl id: 1b4cad2b-3896-f700-e063-6394a90a2fa5
spl set id: 97d506bd-3215-4e2e-9914-af1c174dd4ab

Reported adverse events (FAERS/openFDA)#

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