GL HEALTH BARRIER SKIN PROTECTANT- zinc oxide cream

GL HEALTH Barrier Skin Protectant by

Drug Labeling and Warnings

GL HEALTH Barrier Skin Protectant by is a Otc medication manufactured, distributed, or labeled by GL HEALTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

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

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

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

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

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

Labeler - GL HEALTH, INC. (086010932)