Z-GUARD- white petrolatum,zinc oxide paste

Z-Guard by

Drug Labeling and Warnings

Z-Guard by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

White Petrolatum 57%

Zinc Oxide 17%

Purpose

Skin Protectant

Skin Protectant

Uses

• temporarily protects and helps relieve chapped or cracked skin
• temporarily protects minor cuts, scrapes, and burns
• protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

• For external use only.

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for skin protection
• apply as needed
• for diaper rash
• change wet and soiled diapers promptly
• cleanse area and allow to dry
• apply as needed with each diaper change.

Other information

• Protect from freezing. Avoid excessive heat.

Inactive ingredients

7-dehydrocholesterol, Aphanizomemnon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, Cocos Nucifera (Coconut) Oil, Corn Starch, Dimethicone, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Glycerin, Hydrolyzed Soy Protein, Isopropyl Myristate, Manuka Honey, Methyldihydrojasmonate, Olea Europaea (Olive) Fruit Oil, Paraffin Wax, Phospholipids, Tocopherol Acetate, Vanilla Planifolia Fruit Extract, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil

SPL UNCLASSIFIED SECTION

Phytoplex, Medline Remedy and Medline are registered trademarks of Medline Industries, Inc., Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. Made in USA. www.medline.com 1-800-MEDLINE

Package Label

INGREDIENTS AND APPEARANCE

Z-GUARD 
white petrolatum,zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-137
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	57 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
CLOVE (UNII: K48IKT5321)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)
YEAST (UNII: 3NY3SM6B8U)
VANILLA (UNII: Q74T35078H)
HONEY (UNII: Y9H1V576FH)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
PARAFFIN (UNII: I9O0E3H2ZE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-137-14	57 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2016
2	NDC: 53329-137-44	113 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2016
3	NDC: 53329-137-96	144 in 1 BOX	01/06/2016
3	NDC: 53329-137-16	5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/06/2016

Labeler - Medline Industries Inc. (025460908)