Label: CVS HEALTH MAXIMUM STRENGTH FEMININE- pramoxine hydrochloride cloth

  • 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 January 27, 2017

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  • ACTIVE INGREDIENT

    Active ingredient                                                              Purpose

    Pramoxine hydrochloride 1% w/w......................................Extnernal analgesic

  • PURPOSE

    Use

    temporarily relieves itching

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children 12 years of age and older: Unfold towellete and gently pat or wipes external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.

    Children under 12 years of age: Consult a doctor.

  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • discard within 2 months of opening
  • INACTIVE INGREDIENT

    Inactive ingredients

    water, glycerin, phenoxyethanol, polyaminopropyl biguanide, polysorbate 20, sodium methylparaben, fragrance, benzoic acid, disodium cocamphodiacetate, dehydroacetic acid, aloe barbadensis leaf juice powder, toceopheryl acetate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    CVS Pharmacy, Inc.

    Once CVS Drive,

    Woonsocket, RI 02895

    CVS.com 1-800-SHOP CVS

    Made in China

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MAXIMUM STRENGTH FEMININE 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM (UNII: 9NEZ333N27)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-128-2020 in 1 POUCH; Type 0: Not a Combination Product01/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/26/2017
    Labeler - CVS Pharmacy (062312574)
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