PRECISION PAIN RELIEF AUDACIOUS WRECK RELIEF- lidocaine hcl 4% liquid

Precision Pain Relief by

Drug Labeling and Warnings

Precision Pain Relief 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                                  Purpose

Lidocaine HCl 4%              Topical Anesthetic

PURPOSE

Uses:

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

Warnings For external use only

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

Do not use in large quantities, particularly over raw surfaces and 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 1200F
do not store at temperature above 120 0F

Stop use and ask doctor if condition worsens redness is present irritation develops symptoms persist for more than 7
days or clear up and occur again within a few days

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer Aloe Barbadensis Leaf Extract
Aminomethyl Propanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer Caprylyl Methicone
Cetearyl Alcohol Ceteth-20 Phosphate Dicetyl Phosphate Dimethicone Disodium EDTA
Ethylhexylglycerin
Full Spectrum Hemp Extract
Glyceryl Stearate
Methylparaben
SD Alcohol 40 Steareth-21
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRECISION PAIN RELIEF   AUDACIOUS WRECK RELIEF
lidocaine hcl 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82212-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEMP (UNII: TD1MUT01Q7)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82212-002-02	74 mL in 1 PACKAGE; Type 0: Not a Combination Product	11/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/05/2021

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

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC		081030372	manufacture(82212-002)