MENTHOL, CAMPHOR- menthol, camphor gel 
SUNSET NOVELTIES, INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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72937-006-02
72937-006-04
72937-006-08
72937-006-16

Camphor 2%

Menthol 6%

Topical Analgesic

USES:

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

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

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.

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 consult a doctor

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

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 2oz

SUNSET COOLING PAIN RELIEF 2

SUNSET - COOLING PAIN RELIEF GEL 4oz

SUNSET COOLING PAIN RELIEF 4

SUNSET - COOLING PAIN RELIEF GEL 8oz

SUNSET COOLING PAIN RELIEF 8

SUNSET - COOLING PAIN RELIEF GEL 16oz

SUNSET COOLING PAIN RELIEF 16

MENTHOL, CAMPHOR 
menthol, camphor gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
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)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
THYME OIL (UNII: 2UK410MY6B)  
TEA TREE OIL (UNII: VIF565UC2G)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
Product Characteristics
Colorwhite (Turquoise) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72937-006-0259 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
2NDC:72937-006-04118 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
3NDC:72937-006-08236 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
4NDC:72937-006-16472 g in 1 BOTTLE; Type 0: Not a Combination Product09/08/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/22/2020
Labeler - SUNSET NOVELTIES, INC (067218145)

Revised: 9/2023
Document Id: 05de454d-857a-ce4d-e063-6394a90a2d1d
Set id: f03090fa-f7e6-f53a-e053-2a95a90aa819
Version: 4
Effective Time: 20230921
 
SUNSET NOVELTIES, INC