UtaSpray

Manufacturer
Big 5 Nutrition LLC | Taiwan Shuenn-Ann Biotechnology Pharmaceutical Co., Ltd.
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:36

Label at a glance#

ProductUtaSpray
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure7 sections

Indications and uses

For temporary relief of joint and muscle aches and pains sprains and strains inflammation mild bruises

Dosage and administration

Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl Salicylate 5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of joint and muscle aches and pains

  • sprains and strains
  • inflammation
  • mild bruises

Warnings

WARNINGS SECTION

For external use only

  • Use only as directed
  • Avoid contact with the eyes or mucous membranes
  • Do not use on open wounds or irritated or broken skin
  • Discontinue use if skin rash or irritation develops or if condition worsens
  • Consult your doctor before use if you are pregnant or breastfeeding

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

SPL UNCLASSIFIED SECTION

  • Store at room temperature
  • Shake well before use, close cap tightly after use
  • Read all product information before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean and dry application area. Spray treatment directly onto skin and gently rub in if desired. May be used up to 10 times per day in adults and children over age 2.

Other Ingredients

INACTIVE INGREDIENT SECTION

Saposhnikoviae Radix, Artemisiae Argyi Folium, Moutan Cortex, Cimicfugae Rhizoma, Sophorae Flavescentis Radix, Paeoniae Radix, Rubra Notoginseng Radixet Rhizoma, Carthami Flos, Alcohol.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1875611menthol 10 % / methyl salicylate 5 % Topical SprayPSN2
1875611menthol 100 MG/ML / methyl salicylate 50 MG/ML Topical SpraySCD2
1875611menthol 10 % / methyl salicylate 5 % Topical SpraySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0008-1UtaSpray70 mL in 1 BOTTLELIQUID702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0008UTASPRAY (MENTHOL AND METHYL SALICYLATE) LIQUID [BIG 5 NUTRITION LLC]2Current NDC, Legacy NDC, 1 package rows20231122_c641ab11-cd00-4e23-ace7-8178739084f0.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82198-000882198-0008-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
UtaSprayMENTHOL AND METHYL SALICYLATEBig 5 Nutrition LLCc641ab11-cd00-4e23-ace7-8178739084f02023-11-21WarningsExact identifier
ndc (package): 82198-0008-1
ndc (product): 82198-0008
ndc11 (package): 82198000801
spl id: 0aa37a7b-851a-d9d5-e063-6294a90a23be
spl set id: c641ab11-cd00-4e23-ace7-8178739084f0

Reported adverse events (FAERS/openFDA)#

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