MENTHOL, CAMPHOR- menthol, camphor cream 
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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72937-310-16

Menthol 10%

Camphor 3%

External Analgesic

Pain Relieving

USES:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

Use only as directed.
For external use only.
Do not bandage tightly. Do not use with heating pad, pack, wrap, hot water bottle or any heating element.
Keep away from children. Package not child resistant.

In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to the product, consult to a doctor before using.

Keep away from children. Package not child resistant.

Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin.
Do not apply on nose and genital area. If rash, redness or itchiness results; discontinue use and consult a doctor.

DIRECTIONS:

Adults and children over 12 years of age:

Apply a small amount on desired area.
Massage in circular motions until absorbed.
Repeat as needed but not more than 3 to 4 times a day.
Store tightly closed in a dry place at room temperature between 59°-86°(15°-30°).

Wash hands with soap and water after use.

Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, FD&C Blue #1 Powder (CI 42090).

SUNSET PAIN RELIEF CREAM 8 oz

SUNSET PAIN RELIEF CREAM 8

SUNSET PAIN RELIEF CREAM 16 oz

SUNSET POTENT PAIN RELIEF 16

MENTHOL, CAMPHOR 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BASIC BLUE 1 (UNII: 92N74OA24D)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIBUTYL CITRATE (UNII: 827D5B1B6S)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYDROXYPROLINE (UNII: RMB44WO89X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
GLYCERETH-26 (UNII: NNE56F2N14)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BUTETH-3 (UNII: OC116GRO69)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 1000 (UNII: MCU2324216)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72937-310-16456 g in 1 TUBE; Type 0: Not a Combination Product09/19/202210/10/2024
2NDC:72937-310-08226 g in 1 TUBE; Type 0: Not a Combination Product03/04/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/04/2021
Labeler - SUNSET NOVELTIES, INC (067218145)
Registrant - CHEMCO CORPORATION (032495954)
Establishment
NameAddressID/FEIBusiness Operations
CHEMCO CORPORATION032495954manufacture(72937-310)

Revised: 9/2023
Document Id: 05b87b34-5169-dfbb-e063-6394a90a0104
Set id: bcb8a65b-3b2f-b82f-e053-2a95a90a51af
Version: 7
Effective Time: 20230919
 
SUNSET NOVELTIES, INC