GREEN REMEDY COOLING ROLL ON- cooling roll on gel

GREEN REMEDY COOLING ROLL ON by

Drug Labeling and Warnings

GREEN REMEDY COOLING ROLL ON by is a Otc medication manufactured, distributed, or labeled by EXCLAVE HOLDINGS INC., JOHN SALSMAN, A.I.G. Technologies Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

Water

SD Alcohol 40-B

Spearmint Oil

Glycerin

Full Spectrum Hemp Extract

Aloe Barbadensis Leaf Extract

Holly Extract

Arnica Extract

Bamboo Extract

Pea Extract

Glucosamine HCI

Camphor

Eucalyptus Oil

Peppermint Oil

Dimethyl Sulfoxide

Silica Propylene Glycol

Triethanolamine

Carbomer

INDICATIONS & USAGE

Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.

Shake well before use. Apply liberally to affected area. No need to rub in. Repeat if necessary, no more than 4 times daily. Rinse with soap and water to remove. Wash hands with soap and water after use. For children under 12 years of age, consult a physician.

KEEP OUT OF REACH OF CHILDREN

Intended for adult use only. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Penetrating cooling relief. Temporary relief of minor aches and pains of muscle and joints associated with simple backaches, arthritis, strains, sprains, and bruises.

ACTIVE INGREDIENT

Methyl Salicylate

Menthol

DOSAGE & ADMINISTRATION

Apply liberally to affected area. No need to rub in. Repeat as necessary, no more than 4 times daily.

WARNINGS

For external use only. Keep out of eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage. Do not use with heating pad. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

PRINCIPAL DISPLAY PANEL

89mg NDC: 78461-0002-1

89mg NDC: 78461-0002-1

INGREDIENTS AND APPEARANCE

GREEN REMEDY COOLING ROLL ON 
cooling roll on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78461-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	1 g  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SPEARMINT OIL (UNII: C3M81465G5)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
PEA (UNII: W4X7H8GYFM)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	white (Roll On Applicator)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78461-0002-1	1 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2020

Labeler - EXCLAVE HOLDINGS INC. (117536775)

Registrant - JOHN SALSMAN (117536775)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies Inc.		086365223	manufacture(78461-0002)

Establishment
Name	Address	ID/FEI	Business Operations
EXCLAVE HOLDINGS INC.		117536775	relabel(78461-0002)