Label: GNP ANTI ITCH- camphor, menthol lotion

  • NDC Code(s): 46122-573-10
  • Packager: AMERISOURCEBERGEN DRUG CORPORATION
  • Category: HUMAN OTC DRUG LABEL

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 November 25, 2020

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  • Active Ingredients

    Camphor 0.5%............................................................................................................................ External analgesic

    Menthol 0.5%.............................................................................................................................. External analgesic

  • Uses

    temporary relieves pain and itching due to:

    insect bites

    minor burns

    sunburn

    minor skin irritations

    minor cuts

    scrapes

    rashes due to poison ivy, poison oak, and poison sumac

  • Warning

    For external use only

    Ask doctor before use

    on chicken pox

    on measles

    when using this product

    do not get into eyes

    Stop Use and ask doctor if

    condition worsens

    symptoms last 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.

  • Purpose

    Anti - itch

  • Directions

    to open, squeeze cap tightly and turn pump counter-clockwise

    adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    children under 2 years: ask a doctor

  • Other information

    store at 20 °C to 25 °C (68 °F to 77 °F)

  • Inactive ingredients

    carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate,
    purified water, sodium hydroxide, stearic acid, white petrolatum.

  • Principal Display Panel

    Original Formula Anti-Itch Lotion

    Camphor 0.5%

    Menthol 0.5%

    Steroid Free

    Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

    Cools and Soothes

    Front

  • INGREDIENTS AND APPEARANCE
    GNP ANTI ITCH 
    camphor, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-573
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-573-10212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/25/2020
    Labeler - AMERISOURCEBERGEN DRUG CORPORATION (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo005290028manufacture(46122-573)
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