Label: FIRST AID SENSITIVE ANTI-ITCH- pramoxine hydrochloride 1.0% 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 June 19, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                   Purpose
    Pramoxine Hydrochloride 1.0%.............External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    For temporary relief of pain and itching associated with
    • minor burns • sunburn • minor cuts • scrapes • insect bites
    • minor skin irritations

  • WARNINGS

    Warnings
    For external use only
    When using this product
    • avoid contact with the eyes.
    Stop use and ask a doctor if
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again
    within a few days.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    • To open, squeeze cap tightly and turn pump counter-clockwise. • Adults and
    children 2 years of age and older: Apply to affected area not more than 3 to 4
    times daily. • Children under 2 years of age: Consult a doctor

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice
    Carbomer
    Cetyl Alcohol
    Chamomilla Recutita (Matricaria) Flower Extract
    Ethylhexylglycerin
    Glyceryl Stearate
    Isopropyl Myristate
    PEG-100 Stearate
    PEG-8 Stearate
    Petrolatum
    Phenoxyethanol
    Sodium Hydroxide
    Stearic Acid
    Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    FIRST AID SENSITIVE ANTI-ITCH 
    pramoxine hydrochloride 1.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) Pramoxine Hydrochloride1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    PEG-8 Stearate (UNII: 2P9L47VI5E)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1236-6222 mL in 1 BOTTLE; Type 0: Not a Combination Product12/31/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/31/2012
    Labeler - Rite Aid (014578892)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(11822-1236) , label(11822-1236)
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