Available Formats

• Active ingredient

  Pramoxine hydrochloride 1%

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• Purpose

  external analgesic

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• Use

  for the temporary relief of itching associated with minor skin irritations

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• 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.

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• 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. 

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• Other Information

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

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• 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
  

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• 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

  

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• 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)

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