PAIN RELIEF AUDACIOUS WRECK RELIEF- menthol 4% gel

Pain Relief by

Drug Labeling and Warnings

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 ingredients                             Purpose

Menthol 4%                                       Topical Analgesic

PURPOSE

Uses:

Temporary relief from minor aches pains of muscles and joints associated with simple backache, strains and sprains

Warnings For external use only

When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days i f severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight.

Stop use and ask doctor if condition worsens blistering or burning occurs  pain or swelling occures symptoms persist for more than 7
days or clear up and occur again within a few days

Flammable keep away from fire or flame

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

Aloe Barbadensis Leaf Extract Arctium Lappa Root (Burdock) Extract
Arnica Montana Flower Extract Boswellia Carterii Resin Extract Calendula Officinalis Extract Camellia Sinensis Leaf Extract Camphor
Carbomer FD&C Blue #1
FD&C Yellow #5
Industrial Hemp Extract
Glycerin
Ilex Paraguariensis (Mate) Leaf Extract Isopropyl Alcohol
Isopropyl Myristate
Melissa Officinalis (Lemon Balm) Leaf Extract Silica
Tocopheryl Acetate Triethanolamine
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEF   AUDACIOUS WRECK RELIEF
menthol 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82212-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER 940 (UNII: 4Q93RCW27E)
HEMP (UNII: TD1MUT01Q7)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82212-003-02	89 mL in 1 BOTTLE; 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(82212-003)