MENTHOL, CAMPHOR by EROS GLOBAL / CHEMCO CORPORATION MENTHOL, CAMPHOR cream

MENTHOL, CAMPHOR by

Drug Labeling and Warnings

MENTHOL, CAMPHOR by is a Otc medication manufactured, distributed, or labeled by EROS GLOBAL, CHEMCO CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 3%

Camphor 3%

PURPOSE

External Analgesic

INDICATIONS & USAGE

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.
Use only as directed.
Do not bandage tightly.
Do not use with heating pad, pack, wrap, hot water bottle or any heating element.

If prone to allergic reaction to the product, consult to a doctor before using.

ASK DOCTOR

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

WHEN USING

Avoid contact with eyes, mucous membranes, rashes.
Do not apply to wounds or damaged skin.
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product, and consult a doctor.

If rash, redness or itchiness results; discontinue use and consult a doctor.

PREGNANCY OR BREAST FEEDING

If pregnant or breast – feeding

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Adults and children over 12 years of age

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 unless directed by a doctor.

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

Water (Aqua), Paraffinum Liquidum, Alcohol Denat, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Stearic Acid, Glycereth-26, Propylene Glycol, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Fragrance (Parfum), Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Diazolidinyl Urea, Methylparaben, Propylparaben, FD&C Blue No.1 (CI 42090), Linalool, Limonene, Benzyl Benzoate, Coumarin, Geraniol.

COOL RELIEF CREAM

INGREDIENTS AND APPEARANCE

MENTHOL, CAMPHOR 
menthol, camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80465-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GERANIOL (UNII: L837108USY)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE 1000 (UNII: MCU2324216)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERETH-26 (UNII: NNE56F2N14)
METHYLPARABEN (UNII: A2I8C7HI9T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PANTHENOL (UNII: WV9CM0O67Z)
HYDROXYPROLINE (UNII: RMB44WO89X)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
COMFREY (UNII: D05HXK6R3G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL BENZOATE (UNII: N863NB338G)
TROLAMINE (UNII: 9O3K93S3TK)
COUMARIN (UNII: A4VZ22K1WT)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
AMINO ACIDS, WHEAT (UNII: 0370GZL32F)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80465-003-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	11/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/04/2020

Labeler - EROS GLOBAL (117597821)

Registrant - CHEMCO CORPORATION (032495954)

Establishment
Name	Address	ID/FEI	Business Operations
CHEMCO CORPORATION		032495954	manufacture(80465-003)