FDA.reportPublic FDA data

Pain Relief Body

Manufacturer
Australis Capital (Nevada) Inc. | Inspec Solutions LLC
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:15:58

Label at a glance#

ProductPain Relief Body Audacious Wreck Relief
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For temporary relief of pain and itching due to : sunburn scrapes insect bites minor skin irritations

Label contents#

Full prescribing information#

Active ingredient                       Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4 %                             Topical Anesthetic      

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to :

  • sunburn
  • scrapes
  • insect bites
  • minor skin irritations

WARNINGS SECTION

Warnings
For external use only

Flammable: Do not use while smocking or near heat of flame.

Do not use

OTC - DO NOT USE SECTION

to wounds or damaged skin • do not use in large quantities, particularly over raw surface or blistered areas.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes 
  • use only as directed
  • do not puncture or incinerate
  • content under pressure, do not store at temperature above 120 0F

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

 If accidentally ingested get medical help or contact a Poison Control Center immediately

Direction

DOSAGE & ADMINISTRATION SECTION


• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
• Children under 2 years old: consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Aloe Barbadensis Leaf Extract
Carbomer
Chamomilla Recutita (Matricaria) Flower Extract
Cucumis Sativus (Cucumber) Fruit Extract
Diazolidinyl Urea
Disodium Cocoamphodipropionate
Disodium EDTA
Full Spectrum Industrial Hemp Extract
Glycerin
Propylene Glycol
Simethicone
Tocopheryl Acetate
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82212-001-032025-12-09C16284748780-11030e365-40fa-111a-e063-dadaa90a10e2Drug Facts
82212-001-032024-01-30C16284748780-11030e365-40fa-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82212-001PAIN RELIEF BODY AUDACIOUS WRECK RELIEF (LIDOCAINE) SPRAY [AUSTRALIS CAPITAL (NEVADA) INC.]4Legacy NDC20220118_9c292b44-abe6-4ed1-95c3-eb594aa19e08.zip

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
82212-00182212-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
CARBOMER 9404Q93RCW27EIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
CUCUMBERYY7C30VXJTIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CANNABIS SATIVA WHOLEB5ONF538PBIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

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
458883ed-2ea2-273d-e063-6394a90ad6b89c292b44-abe6-4ed1-95c3-eb594aa19e082025-12-09WarningsExact identifier
spl set id: 9c292b44-abe6-4ed1-95c3-eb594aa19e08

Reported adverse events (FAERS/openFDA)#

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