MENTHOL, CAMPHOR- menthol, camphor cream 
EROS GLOBAL

----------

80465-003-04

Menthol 3%

Camphor 3%

External Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains and strains.

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

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.

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

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.

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

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

cool relief cream

MENTHOL, CAMPHOR 
menthol, camphor cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80465-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80465-003-04113 g in 1 BOTTLE; Type 0: Not a Combination Product11/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/04/2020
Labeler - EROS GLOBAL (117597821)
Registrant - CHEMCO CORPORATION (032495954)
Establishment
NameAddressID/FEIBusiness Operations
CHEMCO CORPORATION032495954manufacture(80465-003)

Revised: 3/2024
Document Id: 137c6781-8bba-de23-e063-6394a90a6abb
Set id: b3495c95-ba4b-9459-e053-2a95a90a710f
Version: 4
Effective Time: 20240312
 
EROS GLOBAL