MENTHOL, CAMPHOR by SUNSET PAIN RELIEF MENTHOL, CAMPHOR cream

MENTHOL, CAMPHOR by

Drug Labeling and Warnings

MENTHOL, CAMPHOR by is a Otc medication manufactured, distributed, or labeled by SUNSET PAIN RELIEF. 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

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

If pregnant 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 thin layer to the 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, 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 GOLD 2 OZ

SUNSET PAIN RELIEF CREAM GOLD 4 OZ

SUNSET PAIN RELIEF CREAM GOLD 8 OZ

SUNSET PAIN RELIEF CREAM GOLD 16 OZ

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72937-010
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
PANTHENOL (UNII: WV9CM0O67Z)
ALCOHOL (UNII: 3K9958V90M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE 1000 (UNII: MCU2324216)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
BENZYL BENZOATE (UNII: N863NB338G)
HYDROXYPROLINE (UNII: RMB44WO89X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERETH-26 (UNII: NNE56F2N14)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRIBUTYL CITRATE (UNII: 827D5B1B6S)
GERANIOL (UNII: L837108USY)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
TROLAMINE (UNII: 9O3K93S3TK)
BUTETH-3 (UNII: OC116GRO69)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
COUMARIN (UNII: A4VZ22K1WT)
CANNABIDIOL (UNII: 19GBJ60SN5)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72937-010-04	113 g in 1 JAR; Type 0: Not a Combination Product	09/15/2023
2	NDC: 72937-010-02	57 g in 1 JAR; Type 0: Not a Combination Product	09/15/2023
3	NDC: 72937-010-08	227 g in 1 JAR; Type 0: Not a Combination Product	09/15/2023
4	NDC: 72937-010-16	454 g in 1 JAR; Type 0: Not a Combination Product	09/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/24/2019

Labeler - SUNSET PAIN RELIEF (067218145)