Label: CAMPHOR cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated July 7, 2022

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  • DOSAGE & ADMINISTRATION

    Apply to affected areas not more than 1-3 times daily.

  • WARNINGS

    For external use only.
    Avoid contact with eyes.
    If you are breastfeeding, consult a health care practitioner prior to use.

  • INACTIVE INGREDIENT

    Aqua, Caprylic/Capric Triglyceride, Paraffinum Liquidum, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Petrolatum, Cetyl Alcohol, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine, Thymus Vulgaris (Thyme) Oil, Stearyl Alcohol, Parfum, Carbomer, Canola Oil, Rosmarinus Officinalis (Rosemary) Oil, Citral, D-Limonene, Geraniol, Linalool.

  • INDICATIONS & USAGE

    Helps relieve respiratory discomfort, cough, and congestion.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children.

  • PURPOSE

    External Analgesic

  • ACTIVE INGREDIENT

    Camphor……………………………………..………………….……... 0.15%

  • PRINCIPAL DISPLAY PANEL

    cream 4oz

  • INGREDIENTS AND APPEARANCE
    CAMPHOR 
    camphor cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80465-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GERANIOL (UNII: L837108USY)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80465-015-04113 g in 1 BOTTLE; Type 0: Not a Combination Product09/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/29/2020
    Labeler - EROS GLOBAL CORP (117597821)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(80465-015)
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