MENTHOL, CAMPHOR by SUNSET NOVELTIES, INC MENTHOL, CAMPHOR cream

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 10%

Camphor 3%

PURPOSE

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.

WARNINGS

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.

WHEN 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 OUT OF REACH OF CHILDREN

Keep away from children. Package not child resistant.

OTHER INFORMATION:

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

INACTIVE INGREDIENT

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 16oz

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-103-02	56 g in 1 BOTTLE; Type 0: Not a Combination Product	10/02/2020
2	NDC: 72937-103-16	452 g in 1 BOTTLE; Type 0: Not a Combination Product	12/05/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/02/2020

Labeler - SUNSET NOVELTIES, INC (067218145)