MAX BARRIER SKIN PROTECTANT- zinc oxide cream

MAX BARRIER Skin Protectant by

Drug Labeling and Warnings

MAX 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 40%

Purpose

Skin Protectant

Uses

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

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 the skin protectant to the area you wish to protect. For diaper rash prevention, 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

MAX BARRIER SKIN PROTECTANT 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82897-468
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	400 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82897-468-00	3.3 mL in 1 PACKET; Type 0: Not a Combination Product	03/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/08/2024

Labeler - GL HEALTH, INC. (086010932)