GREEN FARM POTENT THERMAL RELIEF- methyl salicylate, menthol cream

GREEN FARM POTENT THERMAL RELIEF by

Drug Labeling and Warnings

GREEN FARM POTENT THERMAL 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 10%

Methyl Salicylate 18%

PURPOSE

Topical Analgesic.

USES

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

WARNINGS

For external use only. · Ask a doctor before use if you have redness over affected area

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 transient burning sensation or redness may occur upon application but generally disappears in several days.
If you experience an allergic reaction, discontinue use and consult a doctor.

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

STOP USE AND ASK A DOCTOR IF:

Condition worsens
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.

IF PREGNANT 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.

DIRECTIONS

Adults and Children over 12 years

Apply a small amount on the affected area.
Massage in circular motion, let set for a few seconds.
Repeat as necessary, but no more than 3 to 4 times daily.
Wash hands with soap and water after use.

Children under 12 years of age: do not use, consult a doctor.

INACTIVE INGREDIENT

Water (Aqua), Paraffinum Liquidum, Glyceryl Stearate, Stearic Acid, Cetyl Alcohol, Dimethicone, Glycereth-26, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabidiol, FD&C Yellow No.6 (CI 15985).

OTHER INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

GREEN FARM POTENT THERMAL RELIEF CREAM 2 oz

GREEN FARM POTENT THERMAL RELIEF CREAM 4 oz

GREEN FARM POTENT THERMAL RELIEF CREAM 8 oz

GREEN FARM POTENT THERMAL RELIEF CREAM 16 oz

GREEN FARM POTENT THERMAL RELIEF CREAM SACHET

INGREDIENTS AND APPEARANCE

GREEN FARM POTENT THERMAL RELIEF 
methyl salicylate, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9.8 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	17.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERETH-26 (UNII: NNE56F2N14)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
COMFREY LEAF (UNII: DG4F8T839X)
CANNABIDIOL (UNII: 19GBJ60SN5)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
WATER (UNII: 059QF0KO0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROXYPROLINE (UNII: RMB44WO89X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE 1000 (UNII: MCU2324216)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
MINERAL OIL (UNII: T5L8T28FGP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	orange (Light Orange)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-811-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2022
2	NDC: 72937-811-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2022
3	NDC: 72937-811-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2022
4	NDC: 72937-811-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2022
5	NDC: 72937-811-33	10 mL in 1 PACKET; Type 0: Not a Combination Product	11/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/02/2022

Labeler - SUNSET NOVELTIES, INC (067218145)