FDA.reportPublic FDA data

BlueStop Max

Manufacturer
Clavel Corporation | TAKA USA Inc, dba Cosmetic Innovations
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:34:07

Label at a glance#

ProductBlueStop Max
Active ingredientMENTHOL, LIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INDICATIONS & USAGE SECTION

Temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

Avoid excessive hrat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Alpha-Tocopherol Acetate, Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate and Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.S), Cetyl Alcohol, Coconut Oil, Dimethyl Sulfone, Ethylhexylglycerin,Ethylhexyl Palmitate, Fragrance, Garcinia Indica Seed Butter, Glucosamine Sulfate, Glycerin, Melaleuca Alternifolia Leaf, Phenoxyethanol, Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW), Vitamin A Palmitate, Water, Witch Hazel

Questions or Comments

OTC - QUESTIONS SECTION

1-800-432-5464

Roll-On Label and Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RollOn LabelRollOn LabelCarton Label Front PanelCarton Label Front Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN6
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD6
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130832492046835GTIN-13: 0832492046835
EAN-13: 0832492046835
GTIN-12: 832492046835
UPC-A: 832492046835
GTIN storage (14 digits): 00832492046835		BSM Roller Ball Label.jpg, Roll-On Carton Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82714-001-01BlueStop Max85 g in 1 APPLICATORGEL856
82714-001-01BlueStop Max1 in 1 CARTONGEL16

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82714-00182714-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
GARCINIA INDICA SEED BUTTERUS2H3D7800IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
CETYL ALCOHOL936JST6JCNIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ETHYLHEXYL PALMITATE2865993309IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT

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
BlueStop MaxEXTERNAL ANALGESICClavel Corporationf1efb51c-5217-4cb2-e053-2a95a90a7f952026-01-12WarningsExact identifier
ndc (package): 82714-001-01
ndc (product): 82714-001
ndc11 (package): 82714000101
spl id: 4835cc39-0fd2-f27e-e063-6294a90abf4f
spl set id: f1efb51c-5217-4cb2-e053-2a95a90a7f95

Reported adverse events (FAERS/openFDA)#

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