Sha-lem: Package Insert and Label Information

SHA-LEM- palmitic acid, stearic acid, oleic acid, bismuth subcarbonate and boric acid ointment
Shalem Products, Inc.

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.

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 Type HUMAN OTC DRUG Item Code (Source) NDC:59862-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PALMITIC ACID (PALMITIC ACID) PALMITIC ACID 7.25 g in 30 mL STEARIC ACID (STEARIC ACID) STEARIC ACID 7.25 g in 30 mL OLEIC ACID (OLEIC ACID) OLEIC ACID 14.5 g in 30 mL BISMUTH SUBCARBONATE (BISMUTH CATION) BISMUTH SUBCARBONATE 1.89 g in 30 mL BORIC ACID (BORIC ACID) BORIC ACID 0.95 g in 30 mL

Inactive Ingredients Ingredient Name Strength WHITE WAX

Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59862-100-11 30 mL in 1 JAR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/08/1992

Labeler — Shalem Products, Inc. (075613914)

Establishment
Name	Address	ID/FEI	Operations
Shalem Products, Inc.		075613914	manufacture (59862-100)

Revised: 12/2015 Shalem Products, Inc.