FDA.reportPublic FDA data

Capsaicin 0_035 Percent Cream

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-08-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-25 01:03:18

Label at a glance#

ProductCapsaicin 0.035 Percent
Active ingredientCAPSAICIN
Label structure9 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°C (59°-86°F) Relabeled By: Preferred Pharmaceuticals Inc.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.035%

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

OTC - DO NOT USE SECTION

• On wounds or damaged skin

• If you are allergic to capsicum or chili peppers

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• Condition worsens or does not improve after regular use

• Severe burning persists or blistering occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

STORAGE AND HANDLING SECTION

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

Relabeled By: Preferred Pharmaceuticals Inc.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, and Triethanolamine

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capsaicin 0.035% cream
NDC 68788-4186-1
Net Wt. 100 g

Relabeled By: Preferred Pharmaceuticals Inc.

Capsaicin 0.035% Cream
Capsaicin 0.035% Cream

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1281578capsaicin-0_035-percent-cream-01.jpg
Data codeData Matrix**082026*capsaicin-0_035-percent-cream-01.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1035-1GM - Gram50488-103541964388-d8a5-429d-8c3a-dccbbb9de67212026-04-20

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-418668788-4186-1
50488-1035

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
LAURETH-7Z95S6G8201IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT

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
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
ndc (package): 68788-4186-1
ndc (product): 68788-4186
ndc11 (package): 68788418601
spl id: 0fabc025-4208-45f5-b3c2-543ae3a2df41
spl set id: 0fabc025-4208-45f5-b3c2-543ae3a2df41
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
ndc (product): 50488-1035

Reported adverse events (FAERS/openFDA)#

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