SHA-LEM- palmitic acid, stearic acid, oleic acid, bismuth subcarbonate, 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.

----------

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1)	PALMITIC ACID	7.25 g in 30 mL
STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP)	STEARIC ACID	7.25 g in 30 mL
OLEIC ACID (UNII: 2UMI9U37CP) (OLEIC ACID - UNII:2UMI9U37CP)	OLEIC ACID	14.5 g in 30 mL
BISMUTH SUBCARBONATE (UNII: M41L2IN55T) (BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBCARBONATE	1.89 g in 30 mL
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4)	BORIC ACID	0.95 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59862-100-11	30 mL in 1 JAR; Type 0: Not a Combination Product	05/08/1992

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

Labeler - Shalem Products, Inc. (075613914)

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