Label: SELECT BRAND ANTI-ITCH- menthol and pramoxine hydrochloride cream

  • 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 12, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Menthol 1%

    Pramoxine hydrochloride 1%

  • Purpose

    Topical analgesic

  • Uses

    for temporary relief of pain and itching due to:

    • minor burns
    • sunburn
    • minor cuts
    • scrapes
    • insect bites
    • minor skin irritations
    • minor rashes due to poison ivy, poison oak, or poison sumac
  • Warnings

    For external use only

    When using this product

    do not get into eyes

    Stop use and ask a doctor if

    • condition gets worse
    • 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.

  • Directions

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

    children under 2 years: consult a doctor

  • Other Information

    • store at controlled room temperature
  • Inactive ingredients

    aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Select Brand Medicated Anti-Itch Cream

    Maximum Relief

    Topical Analgesic

    Net wt 1 oz (28.3 g)

    PDP

    rear

  • INGREDIENTS AND APPEARANCE
    SELECT BRAND ANTI-ITCH 
    menthol and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-721
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE.1 g  in 10 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM.1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15127-721-011 in 1 CARTON01/03/2014
    128.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/03/2012
    Labeler - Select Brand (043562370)
    Registrant - Weeks & Leo Co., Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo Co., Inc.005290028label(15127-721) , manufacture(15127-721) , pack(15127-721)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!