Label: SARNA- pramoxine hydrochloride lotion

  • NDC Code(s): 0316-0230-12, 0316-0230-57
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 30, 2024

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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.

    Do not use

    • in the eyes
    • over large areas of the body
    • for prolonged periods

    When using this product

    • avoid contact with eyes
    • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

    Stop use and ask a doctor if

    • redness, irritation, swelling, or pain persists or increases.

    Keep out of reach of children.

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

  • Directions

    • To open, hold cap and turn pump 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: do not use, consult a doctor.
  • Other information

    • store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Citric Acid, Dimethicone, Ethylhexylglycerin, Glyceryl Stearate, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Citrate, Sodium Hydroxide, Squalane, Stearic Acid, Tocopherol, Water

  • Sarna Sensitive Principal Display Panel

    #1 DERMATOLOGIST RECOMMENDED TOPICAL ANTI-ITCH BRAND

    Sarna

    Pramoxine Hydrochloride 1%

    External Analgesic Lotion

    Steroid Free

    SENSITIVE

    ANTI-ITCH LOTION

    • Eases itch associated with minor skin irritations
    • Soothes and conditions with Aloe, Squalene, and Jojoba Oil
    • Hypoallergenic

    NET WT. 7.5fl oz (222 ml)

    Sarna Sensitive

  • 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
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    SQUALANE (UNII: GW89575KF9)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0230-57222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2024
    2NDC:0316-0230-12355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2024
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories, Inc.079035945manufacture(0316-0230)
    Establishment
    NameAddressID/FEIBusiness Operations
    VOYANT BEAUTY, INC.243547333manufacture(0316-0230)
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