MENTHOL, CAMPHOR by SUNSET NOVELTIES, INC / CHEMCO CORPORATION 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, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 3%

Menthol 10%

PURPOSE

Topical Analgesic

USE

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. · Ask a doctor before use if you have redness over affected area

WHEN USING

Use only as directed.

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.

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.

PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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 desired area.
Massage in circular motions until absorbed.
Repeat as needed, but no more than 3 to 4 times per day.
Wash hands with soap and water after use.
Children under 12 years of age: do not use, consult a doctor.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetearyl Alcohol, Polysorbate 60, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Cannabis Sativa Seed Oil, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Polysorbate 20, Triethanolamine, Fragrance (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 No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

SUNSET PAIN RELIEF CREAM 4 oz TUBE LIMITED EDITION

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-310
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
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)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MINERAL OIL (UNII: T5L8T28FGP)
COMFREY (UNII: D05HXK6R3G)
CANNABIDIOL (UNII: 19GBJ60SN5)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-310-42	113 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/04/2021

Labeler - SUNSET NOVELTIES, INC (067218145)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(72937-310)