Label: ANTI-ITCH- camphor 0.5% menthol 0.5% lotion

  • 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 21, 2018

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  • ACTIVE INGREDIENT

    Active ingredients                                  Purpose
    Camphor 0.5%.......................................External Analgesic
    Menthol 0.5%.........................................External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For temporary relief of pain and itching associated with
    • minor burns • sunburn • minor cuts • scrapes • insect bites
    • minor skin irritations

  • WARNINGS

    Warnings
    For external use only
    When using this product • Avoid contact with the eyes.
    Stop use and ask a doctor if • Condition worsens • Symptoms persist
    for more than 7 days or clear up and occur again within a few days.
    Keep out of reach of children. If swallowed, get medical help or contact
    a Poison Control Center right away

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions • Adults and children 2 years of age and older: Apply to
    affected area not more than 3 to 4 times daily. • Children under 2 years
    of age: Consult a doctor.

  • Inactive ingredients

    Carbomer
    Cetyl Alcohol
    DMDM Hydantoin
    Fragrance
    Glyceryl Stearate
    Isopropyl Myristate
    PEG-8 Stearate
    PEG-100 Stearate
    Petrolatum
    Sodium Hydroxide
    Stearic Acid
    Water

  • Questions? 866-483-2846

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    camphor 0.5% menthol 0.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-797
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 mL
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    PEG-8 Stearate (UNII: 2P9L47VI5E)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-797-06222 mL in 1 BOTTLE; Type 0: Not a Combination Product07/02/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/02/2012
    Labeler - Meijer (006959555)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(41250-797) , label(41250-797)
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