Label: MAKESENSE WITH ALOE VERA AND VITAMIN E- camphor menthol 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 June 26, 2014

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  • Active Ingredients

    Camphor 1%

    Menthol 1%

  • Purpose

    External analgesic

    External Analgesic

  • Uses

    For temporary relief of pain and itch associated with ■ dry skin itch ■ insect bites ■ minor cuts & scrapes ■ minor skin irritations
    ■ sunburn

  • Warnings

    For external use only

  • Do not use

    ■

    ■ on wounds or damaged skin ■ with a heating pad ■ on a child under 12 years of age with arthritis-like conditions

  • When using this product

    ■ avoid contact with the eyes

  • Stop use and ask a doctor

    ■ condition worsens or if symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    ■ children under 12 years of age: ask a doctor

  • Other Information

    ■ store at 20 to 25C (68 to 77F)

  • Inactive Ingredients

    Alcohol, Aloe Vera, Carbomer, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Steareth-2, Steareth-21, Triethanolamine, Vitamin E.

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  WITH ALOE VERA AND VITAMIN E
    camphor menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-201-2828 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2014
    Labeler - Cherry Hill Sales Co (145959768)
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