Label: REESES PINWORM ITCH RELIEF- pramoxine hydrochloride cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 2, 2017

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  • Active ingredient

    Pramoxine Hydrochloride 1.0% w/w

  • Purpose

    ANALGESIC

  • Uses

    • Temporarily relieves itching
  • Warnings

    For external use only

  • When using this product

    • Avoid contact with eyes
  • Stop use and ask a doctor if

    • Condition worsens or does not improve within 7 days or clears up and reoccurs within a few days
  • Keep out of the reach of children.

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

  • Direction

    • Adults: unfold wipe and cleanse the area by gently wiping or patting external area from front to back. Use each wipe only once and discard.
    • Use up to 5 times daily.
    • Children under 12: consult a doctor
  • Other information

    • Store at room temperature
    • Discard within 2 months of opening
  • Inactive ingredients

    purified water, glycerin, propylene glycol, cocoamphodiacetate, polysorbate 20, aloe vera barbadensis leaf juice, citric acid, fragrance, diazolidinyl urea, iodopropynyl butylcarbamate.

  • Questions or comments?

    1-800-321-7178

  • Images of representative packaging

    image on carton

  • INGREDIENTS AND APPEARANCE
    REESES  PINWORM ITCH RELIEF
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10956-799
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10956-799-2089 g in 1 PACKAGE; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/21/2013
    Labeler - Reese Pharmaceutical Co (004172052)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guy & O'Neill, Inc.138513069manufacture(10956-799) , label(10956-799)
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