MENTHOL, CAMPHOR by SUNSET NOVELTIES, INC MENTHOL, CAMPHOR gel

MENTHOL, CAMPHOR by

Drug Labeling and Warnings

MENTHOL, CAMPHOR 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

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 or redness may occur upon application but generally disappears 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.

KEEP OUT OF REACH OF CHILDREN

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

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

STOP USE

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.

DIRECTIONS:

Adults and Children over 12 years:

Apply a small amount on the area to be.
Massaged in a circular motion until absorbed.
Repeat as needed, but no more than 3 to 4 times per day.
Store tightly closed in a dry place at 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 COOLING RELIEF GEL 1.7oz

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-600
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 g
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275)	CAMPHOR, (-)-	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CANNABIDIOL (UNII: 19GBJ60SN5)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
SALICYLIC ACID (UNII: O414PZ4LPZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	white (Turquoise)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-600-17	48 g in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/22/2020

Labeler - SUNSET NOVELTIES, INC (067218145)