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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72937-103-02

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.

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.

​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 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

Keep away from children. Package not child resistant.

OTHER INFORMATION:

Store at room temperature 15° - 30°C (59° - 86°F)

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, Cannabidiol, FD&C Blue #1 Powder (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

GREEN FARM PAIN RELIEF CREAM 2oz

GREEN FARM - PAIN RELIEF CREAM

GREEN FARM PAIN RELIEF CREAM 16oz

GREEN FARM - PAIN RELIEF CREAM 16

MENTHOL, CAMPHOR 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72937-103
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
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)  
BASIC BLUE 1 (UNII: 92N74OA24D)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
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)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TROLAMINE (UNII: 9O3K93S3TK)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
ColorgreenScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72937-103-0256 g in 1 BOTTLE; Type 0: Not a Combination Product10/02/2020
2NDC:72937-103-16452 g in 1 BOTTLE; Type 0: Not a Combination Product12/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/02/2020
Labeler - SUNSET NOVELTIES, INC (067218145)

Revised: 12/2022
Document Id: ef1b0e5c-86a1-611d-e053-2995a90ab4a4
Set id: b0b63981-1fe3-3eaa-e053-2a95a90ae4e1
Version: 3
Effective Time: 20221205
 
SUNSET NOVELTIES, INC