Label: SARNA- pramoxine hydrochloride, menthol lotion

  • NDC Code(s): 0316-0234-12, 0316-0234-75
  • Packager: Crown Laboratories, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2024

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  • Active Ingredients

    Menthol 0.5%

    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 or nose
    • over large areas of the body
    • for prolonged periods

    When using this product

    • avoid contact with the 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, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water

  • Questions?

    call 1-833-279-6522

  • Sarna Calm + Cool Principal Display Panel

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    Sarna

    Pramoxine Hydrochloride 1%

    Menthol 0.5%

    External Analgesic Lotion

    Steroid Free

    CALM + COOL

    ANTI-ITCH LOTION

    Eases pain and itch associated with insect bites, sunburn, and poison ivy

    Infused with Witch Hazel Extract

    Cools with Menthol

    NET WT. 7.5fl oz (222 ml)

    P12288.00

    Sarna Calm_Cool

  • INGREDIENTS AND APPEARANCE
    SARNA 
    pramoxine hydrochloride, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1000 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0234-75222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2024
    2NDC:0316-0234-12355 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/05/2024
    Labeler - Crown Laboratories, Inc (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories, Inc079035945manufacture(0316-0234)
    Establishment
    NameAddressID/FEIBusiness Operations
    VOYANT BEAUTY, INC.243547333manufacture(0316-0234)
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