Label: CVS ANTI-ITCH- pramoxine hcl 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 May 3, 2019

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  • Active Ingredients

    Pramoxine HCl 1% 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

    dries the oozing and weeping of poison:

    ivy

    oak

    sumac

  • Warning

    For external use only

    Do not use

    in the eyes or nose

    over large areas of the body

    for prolonged periods

    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

    benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-40 stearate,
    PEG-100 stearate, purified water, sodium hydroxide, stearic acid, white petrolatum

  • Principal Display Panel

    sail .jpg

    CVS Health

    Compare to Sarna Sensitive Anti-Itch Lotion

    Sensitive Formula Anti-Itch Lotion

    Pramoxine Hydrochloride 1 percent

    Steroid Free

    Reduces and Relieves Itching associated with eczema, dry and sensitive skin

  • INGREDIENTS AND APPEARANCE
    CVS ANTI-ITCH 
    pramoxine hcl lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-263-75212 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/14/2016
    Labeler - CVS (062312574)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo005290028manufacture(69842-263)
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