PAIN RELIEF BODY AUDACIOUS WRECK RELIEF- lidocaine spray

Pain Relief Body by

Drug Labeling and Warnings

Pain Relief Body by is a Otc medication manufactured, distributed, or labeled by Australis Capital (Nevada) Inc., Inspec Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                       Purpose

Lidocaine 4 %                             Topical Anesthetic      

PURPOSE

Uses

For temporary relief of pain and itching due to :

• sunburn
• scrapes
• insect bites
• minor skin irritations

WARNINGS

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

• 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

  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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF BODY   AUDACIOUS WRECK RELIEF
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82212-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82212-001-03	142 g in 1 CAN; Type 0: Not a Combination Product	11/08/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/08/2021

Labeler - Australis Capital (Nevada) Inc. (081483723)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(82212-001)