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

Topical Analgesic

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. · 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

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.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast – feeding

Ask a health professional before use.

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, Cetearyl Alcohol, Cetyl Alcohol, Stearic Acid, Dimethicone, Glyceryl Stearate, Glycereth-26, Tocopheryl Acetate, Cannabis Sativa Seed Oil, Propylene Glycol, Polysorbate 60, Diazolidinyl Urea, Methylparaben, Propylparaben, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Fragrance (Parfum), Stearyl Alcohol, Polysorbate 20, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, Cannabidiol, FD&C Yellow No.5 (CI 19140), Geraniol, Hexyl Cinnamal, Amyl Cinnamal, Citronellol, Hydroxycitronellal, Linalool, Coumarin.

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 4 oz TUBE

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM 8 oz TUBE

SUNSET - JOINT AND MUSCLE PAIN RELIEF CREAM SACHET

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	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
CANNABIDIOL (UNII: 19GBJ60SN5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERETH-26 (UNII: NNE56F2N14)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TEA TREE OIL (UNII: VIF565UC2G)
GERANIOL (UNII: L837108USY)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
COUMARIN (UNII: A4VZ22K1WT)
COMFREY LEAF (UNII: DG4F8T839X)
BUTETH-3 (UNII: OC116GRO69)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
CETYL ALCOHOL (UNII: 936JST6JCN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYDROXYPROLINE (UNII: RMB44WO89X)
GLYCERIN (UNII: PDC6A3C0OX)
TRIBUTYL CITRATE (UNII: 827D5B1B6S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHICONE 1000 (UNII: MCU2324216)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALCOHOL (UNII: 3K9958V90M)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
PANTHENOL (UNII: WV9CM0O67Z)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-300-40	115 g in 1 TUBE; Type 0: Not a Combination Product	06/23/2023
2	NDC: 72937-300-80	230 g in 1 TUBE; Type 0: Not a Combination Product	06/23/2023
3	NDC: 72937-300-33	10 g in 1 POUCH; Type 0: Not a Combination Product	06/26/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/04/2020

Labeler - SUNSET NOVELTIES, INC (067218145)