Capsaicin Cream 0.075%

Manufacturer
Pharmaceutica North America, Inc.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:45

Label at a glance#

ProductCapsaicin Cream 0.075%
Active ingredientCAPSAICIN
Label structure8 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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin Cream 0.075%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

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

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
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 treated area
• do not apply heat 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 or blistering occurs
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45861-075-05GM - Gram45861-0752e7ee3dd-d3f0-44e8-b6ea-f1777e4677da12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45861-07545861-075-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
471bf036-34e9-765c-e063-6294a90a06ad2efe1f19-2aad-475f-aa76-9f64e7596d932025-12-29WarningsExact identifier
spl id: 471bf036-34e9-765c-e063-6294a90a06ad
spl set id: 2efe1f19-2aad-475f-aa76-9f64e7596d93

Reported adverse events (FAERS/openFDA)#

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