FDA.reportPublic FDA data

pain relief roll-on

Manufacturer
Bionpharma Inc. | Pharma Nobis, LLC
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:35

Label at a glance#

Productpain relief roll-on
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

For temporarily relief of pain and itching.

Dosage and administration

Adults and children 2 years of age and older : apply to the affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporarily relief of pain and itching.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor

OTC - STOP USE SECTION

If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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 2 years of age and older: apply to the affected area no more than 3 to 4 times daily.

Children under 2 years of age: consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Methylparaben, polysorbate 60, SD Alcohol 40, Steareth-21, Purified Water

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*compare to the active ingredient

in Aspercreme® Odor Free

with 4 % Lidocaine

NDC 69452-393-63

a+health™

maximum strength

pain relief

roll-on

lidocaine 4% HCl/

topical analgesic

odor free

no mess applicator

  • temporarary relief of pain
  • helps pain-affected areas

without irritation

2.5 fl oz (74mL)

with aloe

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN2
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD2
1987647lidocaine hydrochloride 4 % Topical SolutionSY2

DailyMed Pharmacologic Classes#

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

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
69452-393-63pain relief roll-on74 mL in 1 BOTTLE, WITH APPLICATORLIQUID742
69452-393-63pain relief roll-on1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-393PAIN RELIEF ROLL-ON (LIDOCAINE 4%) LIQUID [BIONPHARMA INC.]2Current NDC, 2 package rows20241225_f607b6dc-8d13-604a-e053-2995a90a59ab.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-39369452-393-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
STEARETH-2153J3F32P58IACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
pain relief roll-onLIDOCAINE 4%Bionpharma Inc.f607b6dc-8d13-604a-e053-2995a90a59ab2024-12-23WarningsExact identifier
ndc (package): 69452-393-63
ndc (product): 69452-393
ndc11 (package): 69452039363
spl id: 29f92d33-ff52-1181-e063-6394a90a6211
spl set id: f607b6dc-8d13-604a-e053-2995a90a59ab

Reported adverse events (FAERS/openFDA)#

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