Label: SARNA- pramoxine hydrochloride 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 February 13, 2023

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  • Active ingredient

    Pramoxine Hydrochloride - 1%

  • Purpose

    External analgesic

  • Uses

    • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac
  • 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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    • to open, hold 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
  • Other information

    Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

  • Inactive ingredients

    benzyl alcohol, carbomer homopolymer type C, cetyl alcohol, dimethicone, glyceryl monostearate, isopropyl myristate, petrolatum, polyoxyl 8 stearate, polyoxyl 100 stearate, purified water, sodium hydroxide, stearic acid

  • Questions or comments?

    Call 1-833-279-6522

  • Principal Display Panel

    #1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

    NDC 0316-0230-75

    Steroid-Free

    Sarna SENSITIVE

    Pramoxine Hydrochloride 1%

    EXTERNAL ANALGESIC LOTION

    ITCH RELIEF

    Moisturizes and gently relieves itch associated with:

    Eczema and

    Dry, Sensitive Skin


    Net wt. 7.5 fl oz (222 mL)

    Sarna is registered trademark of Crown Laboratories, Inc.

    Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

    ©2019 Crown Laboratories, Inc.

    p1170101

  • INGREDIENTS AND APPEARANCE
    SARNA 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0230-75222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/22/2011
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories, Inc.079035945manufacture(0316-0230)
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