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Sha-lem

Dosage form: ointment
Ingredients: PALMITIC ACID 7.25g in 30mL, STEARIC ACID 7.25g in 30mL, OLEIC ACID 14.5g in 30mL, BISMUTH SUBCARBONATE 1.89g in 30mL, BORIC ACID 0.95g in 30mL
Labeler: Shalem Products, Inc.
NDC Code: 59862-100

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Sha'-lemTM OINTMENT

Drug Facts

Active Ingredients

Palmitic Acid, Stearic Acid, Oleic Acid, Bismuth Subcarbonate, Boric Acid

Purpose

Skin Protectant

Keep Out Of Reach of Children

Uses

Helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips. Temporary protection of minor cuts, scrapes, burns and sunburn. Use on most forms of skin irritations, rashes, non-poisonous insect bites.

Warnings

Skin Protectant For External Use Only

DIRECTIONS: Apply liberally as often as needed. If condition worsens or does not improve within seven days, consult a doctor

Inactive ingredient

White wax

To Order Call Toll Free: 1-877-741-1682

Shalem Products, Inc., Angora, MN 55703

Reg. U.S. Patent Off.

Packaging

SHA-LEM 
palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, boric acid ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59862-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PALMITIC ACID (PALMITIC ACID) PALMITIC ACID7.25 g  in 30 mL
STEARIC ACID (STEARIC ACID) STEARIC ACID7.25 g  in 30 mL
OLEIC ACID (OLEIC ACID) OLEIC ACID14.5 g  in 30 mL
BISMUTH SUBCARBONATE (BISMUTH CATION) BISMUTH SUBCARBONATE1.89 g  in 30 mL
BORIC ACID (BORIC ACID) BORIC ACID0.95 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WHITE WAX 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59862-100-1130 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/08/1992
Labeler - Shalem Products, Inc. (075613914)
Establishment
NameAddressID/FEIOperations
Shalem Products, Inc.075613914manufacture(59862-100)

Revised: 12/2015
 
Shalem Products, Inc.

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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