SARNA- pramoxine hydrochloride lotion

Sarna by

Drug Labeling and Warnings

Sarna by is a Otc medication manufactured, distributed, or labeled by Physicians Total Care, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)