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

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 physician

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:

Directions

Adults and Children over 12 years

Apply a small amount on the affected area.
Massage in circular motion until absorbed.
Repeat as needed, but no more than 3 to 4 times per day.
Wash hands with soap and water after use.

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Water (Aqua), Alcohol Denat, Propylene Glycol, Polysorbate 20, Carbomer, Sodium Hydroxide, Salicylic Acid, Glycerin, Mentha Piperita (Peppermint) 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 No. 1 (CI 42090), FD&C Yellow No.5 (CI 19140).

SUNSET - COOLING PAIN RELIEF GEL 4oz TUBE

SUNSET - COOLING PAIN RELIEF GEL 8oz TUBE

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-006
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
PEPPERMINT OIL (UNII: AV092KU4JH)
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)
ROSEMARY OIL (UNII: 8LGU7VM393)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
THYME OIL (UNII: 2UK410MY6B)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALCOHOL (UNII: 3K9958V90M)
CANNABIDIOL (UNII: 19GBJ60SN5)

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: 72937-006-40	118 g in 1 TUBE; Type 0: Not a Combination Product	06/23/2023
2	NDC: 72937-006-80	235 g in 1 TUBE; Type 0: Not a Combination Product	06/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/22/2020

Labeler - SUNSET NOVELTIES, INC (067218145)