FDA.reportPublic FDA data

SERA RELIEF ULTIMATE RAPID SOOTHING CREME

Manufacturer
Sera Labs, Inc., The
Effective date
2019-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:34

Label at a glance#

ProductSERA RELIEF ULTIMATE RAPID SOOTHING CREME
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

Other information: store in cool dry place

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: Temporarily relief from minor pain associated with: • arthritis • bruises • simple backache • muscle strains • cramps • sprains

WARNINGS SECTION

Warning: For external use only
Flammable: Keep away from excessive heat or open flame

When using this product: Avoid contact with eyes or mucous membrane. Do not apply to wounds, damaged, blistered or irritated skin. Do not use with other ointments, creams, sprays or liniments. Do not bandage. Wash hands after use with cool water. Do not use with heating pad or device.

Ask a doctor before use if you have sensitive skin. Stop use if condition worsens or persists for more than 7 days.

If pregnant or breast feeding: ask doctor before using

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: if accidentally ingested get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Recommended Use: Adults, with container rub a thin film over affected areas, not more than 3-4 times in 24 hour period, massage is not necessary.

STORAGE AND HANDLING SECTION

Other information: store in cool dry place

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Allantoin, Caprylic/Capric Triglyceride, Capsicum Annuum Fruit powder, Calcium Disodium EDTA, Cannabis Sativa (Aerial) Extract Oil, DL-Alpha Tocopheryl Acetate, Ethyl Alcohol, Ethylhexylglycerin, Ethylhexyl Stearate, Glycerin, Phenoxyethanol, Polysorbate 80, Propanediol, Propylene Glycol, Purified Water, Simethicone, Sodium Polyacrylate, Trideceth-6, Vitis Vinifera (Grape) seed Oil, Xanthan Gum, Beta – Caryophyllene

SPL UNCLASSIFIED SECTION

Feet & Legs

4% LIDOCAINE

WITH CBD 300mg

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

finalfinal

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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73385-104-602021-01-29C16284748780-1ba0f9c33-158d-a910-e053-dadaa90a0b85SERA RELIEF ULTIMATE RAPID SOOTHING CREME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73385-104-60SERA RELIEF ULTIMATE RAPID SOOTHING CREME73 mL in 1 BOTTLECREAM731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73385-104SERA RELIEF ULTIMATE RAPID SOOTHING CREME (LIDOCAINE HCL) CREAM [SERA LABS, INC., THE]1Legacy NDC, 1 package rows20191121_b33a3a3e-195a-42ae-8e70-cfc859376736.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73385-10473385-104-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALLANTOIN344S277G0ZIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PAPRIKAX72Z47861VIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP8X454SZ22DIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALCOHOL3K9958V90MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TRIDECETH-63T5PCR2H0CIACT
GRAPE SEED OIL930MLC8XGGIACT
XANTHAN GUMTTV12P4NEEIACT
CARYOPHYLLENEBHW853AU9HIACT

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
ae7de482-afd8-4ba5-bc5f-d520f3a7e64db33a3a3e-195a-42ae-8e70-cfc8593767362019-10-25WarningsExact identifier
spl id: ae7de482-afd8-4ba5-bc5f-d520f3a7e64d
spl set id: b33a3a3e-195a-42ae-8e70-cfc859376736

Reported adverse events (FAERS/openFDA)#

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