GREEN FARM POTENT COOLING RELIEF- menthol, camphor gel

GREEN FARM POTENT COOLING RELIEF by

Drug Labeling and Warnings

GREEN FARM POTENT COOLING RELIEF by is a Otc medication manufactured, distributed, or labeled by SUNSET NOVELTIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 6%

Camphor 2%

PURPOSE

Topical Analgesic.

Pain Relieving.

USES:

Aid for temporary local relief of minor pain in muscles or joints.

WARNINGS

For external use only.

WHEN USING

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 transcient burning sensation or redness may occur upon application but generally dissapears in several days.

If you experience an allergic reaction, discontinue use, and consult a physician.

Do not expose the area treated with product to heat or direct sunlight.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE AND ASK A DOCTOR IF:

Conditions worsen
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up occur again within a few days

You experience signs injury, such as pain, swelling or blistering where the product was applied.

DIRECTIONS:

Adults and Children over 12 years:

Apply a small amount on desired area.
Massage in circular motions until absorbed
Repeat as necessary, but no more than 3 to 4 times per day.
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

Wash hands with soap and water after use.

INACTIVE INGREDIENT

Aqua, Alcohol Denat, Propylene Glycol, Salicylic Acid, Glycerin, Polysorbate 20, Carbomer, Sodium Hydroxide, Mentha Arvensis Herb Oil, Rosmarinus Officinalis (Rosemary) Oil, Thymus Vulgaris (Thyme) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cannabis Sativa Seed Oil, Benzyl Alcohol, Sorbic Acid, Cannabidiol, FD&C Blue. 1 Powder (CI 42090), FD&C Yellow. 5 (CI 19140).

GREEN FARM POTENT COOLING RELIEF GEL 2 oz

GREEN FARM POTENT COOLING RELIEF GEL 4 oz

GREEN FARM POTENT COOLING RELIEF GEL 8 oz

GREEN FARM POTENT COOLING RELIEF GEL 16 OZ

INGREDIENTS AND APPEARANCE

GREEN FARM POTENT COOLING RELIEF 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
ROSEMARY OIL (UNII: 8LGU7VM393)
THYME OIL (UNII: 2UK410MY6B)
TEA TREE OIL (UNII: VIF565UC2G)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBIC ACID (UNII: X045WJ989B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CANNABIDIOL (UNII: 19GBJ60SN5)

Product Characteristics
Color	turquoise	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-026-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022
2	NDC: 72937-026-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022
3	NDC: 72937-026-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022
4	NDC: 72937-026-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/05/2022

Labeler - SUNSET NOVELTIES, INC (067218145)