SUNSET PAIN RELIEF - COOLING RELIEF- menthol stick

SUNSET PAIN RELIEF - COOLING RELIEF by

Drug Labeling and Warnings

SUNSET PAIN RELIEF - 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 10%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

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
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.

OTHER SAFETY INFORMATION

FLAMMABLE:

Keep away from fire or flame.

PREGNANCY OR BREAST FEEDING

IF PREGNANT OR BREAST – FEEDING:

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDEN

STOP USE

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.

DOSAGE & ADMINISTRATION

Adults and Children over 12 years:

Apply a small amount on the area to be.
Massaged in a circular motion, let set for a few seconds.

Repeat as necessary, but no more than 3 to 4 times daily.

INACTIVE INGREDIENT

Cocos Nucifera Oil (Organic), Cetyl Esters, Tribehenin, Beeswax, Cannabis Sativa Seed Oil, Butyrospermum Parkii Butter, Cetyl Alcohol, Tocopherol, Eucalyptus Globulus Leaf Oil, Mentha Arvensis Herb Oil, Cannabidiol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Arnica Montana Flower Extract.

SUNSET - PAIN RELIEF + 500 CBD OIL COOLING RELIEF STICK

INGREDIENTS AND APPEARANCE

SUNSET PAIN RELIEF - COOLING RELIEF 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TEA TREE OIL (UNII: VIF565UC2G)
COCONUT OIL (UNII: Q9L0O73W7L)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
TOCOPHEROL (UNII: R0ZB2556P8)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
EUCALYPTUS OIL (UNII: 2R04ONI662)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
CETYL ESTERS WAX (UNII: D072FFP9GU)
PEG-8 BEESWAX (UNII: 3C1QUF1TIR)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-011-01	30 mL in 1 CYLINDER; Type 0: Not a Combination Product	09/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/08/2022

Labeler - SUNSET NOVELTIES, INC (067218145)