MENTHOL, CAMPHOR- menthol, camphor cream 
EROS GLOBAL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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80465-003-04

Menthol 3%

Camphor 3%

Menthol 3%……………………...…………………. PURPOSE: External Analgesic

Camphor 3% ...................................................... PURPOSE: Pain Relieving

Avoid contact with eyes, mucous membranes, rashes, wounds or damaged skin.
Do not apply on nose and genital area.

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

* Adults and children over 12 years of age; apply a thin layer to 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 doctor/physician

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

Keep away from children. Package not child resistant.

In case of accidental ingestion, contact doctor immediately. If prone to allergic reaction to the product, consult to a doctor before using.

Aqua, Paraffinum Liquidum, Alcohol Denat, Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycereth-26, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Stearyl Alcohol, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Triethanolamine, Parfum, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, FD&C Blue 1 Powder (CI 42090)

4oz

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
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)  
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 not finalpart34811/04/2020
Labeler - EROS GLOBAL (117597821)
Registrant - CHEMCO CORPORATION (032495954)
Establishment
NameAddressID/FEIBusiness Operations
CHEMCO CORPORATION032495954manufacture(80465-003)

Revised: 6/2022
Document Id: e2882ba8-7281-f9ed-e053-2a95a90a0269
Set id: b3495c95-ba4b-9459-e053-2a95a90a710f
Version: 3
Effective Time: 20220628
 
EROS GLOBAL