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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72937-310-04

Adults and children over 12 years of age; apply a thin layer to affected area and rub gently not more than 3 to 4 times a day.
Wash hands with soap and water after use.

Children under 12 years of age; do not use unless directed by doctor/physician

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.

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

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).

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

Keep away from children. Package not child resistant.

External Analgesic

Pain Relieving

Menthol 10%

Camphor 3%

4oz

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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE 1000 (UNII: MCU2324216)  
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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERETH-26 (UNII: NNE56F2N14)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
BUTETH-3 (UNII: OC116GRO69)  
BASIC BLUE 1 (UNII: 92N74OA24D)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72937-310-04113 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: 7/2022
Document Id: e39e0c2b-925b-8a42-e053-2995a90a7943
Set id: bcb887e3-1ea7-48f2-e053-2995a90a4be1
Version: 4
Effective Time: 20220712
 
SUNSET NOVELTIES, INC