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Sarna by Physicians Total Care, Inc.

Dosage form: lotion
Ingredients: PRAMOXINE HYDROCHLORIDE 1mg in 1mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-1587

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 Facts

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 
pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-1587(NDC:0145-0630)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
CETYL ALCOHOL 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
POLYOXYL 8 STEARATE 
POLYOXYL 100 STEARATE 
PETROLATUM 
WATER 
SODIUM HYDROXIDE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:54868-1587-0222 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/28/2008
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel(54868-1587)

Revised: 09/2012
 
Physicians Total Care, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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