BARRIER BALM- skin protectant ointment

Barrier Balm by

Drug Labeling and Warnings

Barrier Balm by is a Otc medication manufactured, distributed, or labeled by PROJECT CHEMISTRY, INC., Packaging On Demand, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 15%

PURPOSE

Skin Protectant

WARNINGS

Warnings:

For external use only.

WHEN USING

When using this product, avoid wounds and contact with eyes.

STOP USE

Stop use and ask a doctor if condition worsens or doesn't improve

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, contact a physician or poison control center immediately.

DOSAGE & ADMINISTRATION

Directions:

Apply a thin layer as needed to clean, dry skin.

INACTIVE INGREDIENT

Inactive Ingredients Hydrogenated Soybean Oil, Coconut Alkanes, Silica, Hydrogenated Soy Polyglycerides, C15-23 Alkane, Madecassoside, Asiaticoside, Centella Asiatica Leaf Extract, Hippophae Rhamnoides Seed Oil, Moringa Oleifera Seed Oil, Coco-Caprylate, Tocopheryl Acetate, Menthol.

INDICATIONS & USAGE

To help prevent and relieve skin irritation from wetness.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BARRIER BALM 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75523-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
C15-23 ALKANE (UNII: J3N6X3YK96)
ASIATICOSIDE (UNII: PKO39VY215)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
MENTHOL (UNII: L7T10EIP3A)
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
COCONUT ALKANES (UNII: 1E5KJY107T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75523-200-02	57 g in 1 TUBE; Type 0: Not a Combination Product	10/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/19/2022

Labeler - PROJECT CHEMISTRY, INC. (117491807)

Establishment
Name	Address	ID/FEI	Business Operations
Packaging On Demand, Inc.		610511326	manufacture(75523-200)