FDA.reportPublic FDA data

Lansinoh Pain Relieving Spray

Manufacturer
Lansinoh Laboratories Inc | Dhaliwal Pharmaceuticals Laboratories LLC
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:12:44

Label at a glance#

ProductLansinoh Pain Relieving
Active ingredientLIDOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active IngredientPurpose
Lidocaine 4%Topical Analgesic

STOP USE AND ASK A DOCTOR

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few day

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.

WARNINGS

WARNINGS AND PRECAUTIONS SECTION


Warnings
For external use only.
Do NOT use on breasts, nipples, in or
near mouth.
KEEP OUT OF REACH OF CHILDREN. Do
not use on infants or children under 12.
If swallowed, get medical help or contact
a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ Condition worsens
■ Symptoms persist for more than 7 days
■ Symptoms clear up and return within a
few days

DOSAGE & ADMINISTRATION SECTION

Directions ■ For adult use only
■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.

Distributed By: Lansinoh Laboratories, Inc
Alexandria, VA 22314, USA
Tel: +1-800-292-4794 | www.lansinoh.com

WARNINGS SECTION

FOR EXTERNAL USE ONLY

INDICATIONS & USAGE SECTION

For external use only

OTC - PURPOSE SECTION

Topical Analgesic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelCartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1869797lidocaine 4 % Topical SprayPSN8
1869797lidocaine 40 MG/ML Topical SpraySCD8
1869797lidocaine 4 % Topical SpraySY8

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53997-001-01Lansinoh Pain Relieving100 mL in 1 BOTTLE, PLASTICSPRAY1008
53997-001-02Lansinoh Pain Relieving1 in 1 CARTONSPRAY18

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53997-00153997-001-01, 53997-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA WHOLEKIZ4X2EHYXIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
EUGENOL3T8H1794QWIACT
ALCOHOL3K9958V90MIACT
WITCH HAZEL101I4J0U34IACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
SODIUM BENZOATEOJ245FE5EUIACT
POLOXAMER 188LQA7B6G8JGIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ALMOND OIL66YXD4DKO9IACT
PEPPERMINT OILAV092KU4JHIACT
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%)0Z2R7OG99LIACT
LAVENDER OILZBP1YXW0H8IACT
PHYTATE SODIUM88496G1ERLIACT

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
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
ndc (package): 53997-001-02
ndc (package): 53997-001-01
ndc (product): 53997-001
ndc11 (package): 53997000102
ndc11 (package): 53997000101
spl id: 3e17a936-54d6-845f-e063-6394a90a9fc9
spl set id: b7cf1fdb-946d-a4e8-e053-2995a90a26a8

Reported adverse events (FAERS/openFDA)#

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