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Sarna (Physicians Total Care, Inc.)

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LOTION 222 mL in 1 BOTTLE, PUMP (54868-1587-0) Label Information

Complete Sarna Information

  • Active ingredient

    Pramoxine hydrochloride 1%


  • Purpose

    external analgesic


  • Use

    for the temporary relief of itching associated with minor skin irritations


  • 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.

    Caution -- Do not use in the eyes or nose. Not for prolonged use. Do not apply to large areas of the body. If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by a physician.

    Keep out of reach of children.

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


  • 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. 


  • Other Information

    Side effects may be reported to 1-888-438-7426


  • Inactive ingredients

    benzyl alcohol, carbomer 940, cetyl alcohol, dimethicone, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid

    Find more about Sarna!

    Stiefel Laboratories, Inc.

    Research Triangle Park, NC 27709

    www.sarna-skincare.com

    Made in Canada

    A099718

    Additional barcode labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma       74146


  • Principal Display Panel

    NDC 54868-1587-0

    Sarna®

    SENSITIVE

    Pramoxine Hydrochloride 1%

    ANTI-ITCH LOTION

    Steroid-Free and Fragrance-Free

    DERMATOLOGIST Recommended

    • Relieves itching associated with:

    DRY, SENSITIVE SKIN

    ECZEMA

    • Moisturizing

    Net Wt. 7.5 Fl Oz. (222 mL)

    A099717

    Sarna Sensitive 7.5 fl. oz. (222 mL) front label


  • INGREDIENTS AND APPEARANCE
    SARNA 
    pramoxine hydrochloride lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-1587(NDC:0145-0630)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 8 STEARATE (UNII: 2P9L47VI5E)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-1587-0 222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/28/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel(54868-1587)