BRONSON SOOTHE CREAM Pain Relief Cream

Manufacturer
BRONSON NUTRITIONALS, LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:07

Label at a glance#

ProductBRONSON SOOTHE Pain Relief
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

For temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

Apply directly to affected area. Do not use more than four times per day.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

PURPOSE

OTC - PURPOSE SECTION

External Analgesic

USES:

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of the muscles and joints associted with simple backache, arthritis, strains, bruises and sprains.

WARNINGS

WARNINGS SECTION

  • For external use only. 
  • Avoid contact with eyes.
  • Do not apply to open wounds or damaged skin.
  • If symtoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, contact physician.
  • Do not bandage tightly .
  • If pregnant or breast feeding, contact physician prior to use.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply directly to affected area. Do not use more than four times per day.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Aloe barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica montana Flower Extract, Ascorbyl Palmitate (Vitamin C), C13-14 Isoparaffin, Cetyl Alcohol, Chamomilla recutita (Chamomile) Extract, Diazolidinyl Urea, Emu Oil, Hamamelis virginiana (Witch Hazel) Distillate, Isopropyl Alcohol, Isopropyl Myristate, Lamium album (White Nettle) Extract, Laureth-7, Menthol, Methyl Paraben, Methylsulfonylmethane (MSM), Parfum (Fragrance), PEG-8, Polyacrylamide, Propyl Paraben, Propylene Glycol, Sorbitol, Tocopheryl Acetate (Vitamin E).

OTHER INFORMATION:

SPL UNCLASSIFIED SECTION

  • Store at room temperature.
  • Protect from light.

Package Labeling:59ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label59mlLabel59ml

Package Labeling:118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label118mlLabel118ml

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198555capsaicin 0.025 % Topical CreamPSN2
198555capsaicin 0.25 MG/ML Topical CreamSCD2
198555capsaicin 0.025 % Topical CreamSY2

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
83158-387-02BRONSON SOOTHE Pain Relief59 mL in 1 TUBECREAM592
83158-387-04BRONSON SOOTHE Pain Relief118 mL in 1 TUBECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83158-387BRONSON SOOTHE PAIN RELIEF (CAPSAICIN) CREAM [BRONSON NUTRITIONALS, LLC]2Current NDC, Legacy NDC, 2 package rows20231106_cedf8f43-b9a3-4a06-b3a1-cf82668541f8.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83158-38783158-387-02, 83158-387-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
ndc (package): 83158-387-02
ndc (package): 83158-387-04
ndc (product): 83158-387
ndc11 (package): 83158038702
ndc11 (package): 83158038704
spl id: 0976edf3-b97e-fff9-e063-6294a90a2c4e
spl set id: cedf8f43-b9a3-4a06-b3a1-cf82668541f8

Reported adverse events (FAERS/openFDA)#

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