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Sarna by Stiefel Laboratories, Inc

Dosage form: lotion
Ingredients: CAMPHOR (NATURAL) 0.6mg in 1mL, MENTHOL 0.6mg in 1mL
Labeler: Stiefel Laboratories, Inc
NDC Code: 0145-0628

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

Camphor 0.5%

Menthol 0.5%

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/oak/sumac

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.

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 thin layer to affected skin area only up to 4 times daily. Do not use on broken, reddened and swollen skin.
avoid nostrils and mouth
rinse well with water in case of accidental contact with eyes
do not apply to large areas of the body
if irritation or allergic reaction occurs (rash, reddening, pain, itchiness, burning sensation, blistering or swelling) consult a doctor
do not use if you are allergic to camphor, menthol or any of the ingredients

Children under 2 years of age: consult a doctor.  Do not use around the nostrils of babies or infants.

Other information

Store at or below 30°C (86°F). Check with your doctor if you are planning to become pregnant or breast-feeding.

Inactive ingredients

carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl stearate, isopropyl myristate, PEG-8 stearate, PEG-100 stearate, petrolatum, purified water, sodium hydroxide, stearic acid.

Questions?

Call 1-888-438-7426

Principal Display Panel

NDC 0145-0628-05

Sarna®

ORIGINAL

Camphor 0.5%, Menthol 0.5%

DERMATOLOGIST Recommended

Steroid-Free

ANTI-ITCH LOTION

Relieves itching associated with:

DRY SKIN

INSECT BITES

 POISON IVY/OAK/SUMAC

SUNBURN

Soothes irritated skin

Stiefel

Skin Science Solutions

Net Wt. 7.5 Fl Oz. (222 ml)

Dist.:

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

www.sarna-skincare.com

Sarna is a registered trademark of Stiefel Laboratories, Inc.

Front Label: 104087XA

Back Label: 104086XA

SARNA 
camphor and menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0145-0628
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)0.6 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CETYL ALCOHOL 
DMDM HYDANTOIN 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
PEG-8 STEARATE 
PEG-100 STEARATE 
PETROLATUM 
WATER 
SODIUM HYDROXIDE 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:0145-0628-05222 mL in 1 BOTTLE, PUMP
2NDC:0145-0628-6220 TUBE in 1 CARTON
2NDC:0145-0628-615 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/22/2011
Labeler - Stiefel Laboratories, Inc (808842343)

Revised: 01/2016
 
Stiefel Laboratories, 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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