Drug Facts

Active ingredients

Zinc Oxide 20.5%

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash • Protects chafed skin due to wetness and helps seal out wetness

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and talk to a doctor if

condition worsens or does not improve after 7 days

Keep out of the reach of children

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately

Directions

Apply a layer of Barrier® to skin area you wish to protect. Change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.

Inactive ingredients

Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)

Questions?

Call 1-708-381-0334

Package Labeling:

Label

GL HEALTH BARRIER SKIN PROTECTANT
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82897-379
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	205 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE (UNII: V5VD430YW9)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82897-379-00	113.4 g in 1 TUBE; Type 0: Not a Combination Product	12/16/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	12/16/2022

Labeler - GL HEALTH, INC. (086010932)

GL HEALTH Barrier Skin Protectant