PAIN RELIEF BODY  AUDACIOUS WRECK RELIEF- lidocaine spray 
Australis Capital (Nevada) Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient                       Purpose

Lidocaine 4 %                             Topical Anesthetic      

Uses

For temporary relief of pain and itching due to :

Warnings
For external use only

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

Do not use

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

When using this product

Stop use and ask doctor if

 • 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.

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

Direction


• 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

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

image description

PAIN RELIEF BODY   AUDACIOUS WRECK RELIEF
lidocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82212-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALOE (UNII: V5VD430YW9)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
CUCUMBER (UNII: YY7C30VXJT)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82212-001-03142 g in 1 CAN; Type 0: Not a Combination Product11/08/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/08/2021
Labeler - Australis Capital (Nevada) Inc. (081483723)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC081030372manufacture(82212-001)

Revised: 1/2022
Document Id: d5ccf9c6-4ec0-92f7-e053-2a95a90aeae4
Set id: 9c292b44-abe6-4ed1-95c3-eb594aa19e08
Version: 4
Effective Time: 20220117
 
Australis Capital (Nevada) Inc.