Active ingredient

White Petrolatum 57%

Zinc Oxide 17%

Purpose

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

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

Label Packet

Label Box Label Tube 113 g Label Tube 57 g

Z-GUARD
white petrolatum,zinc oxide paste

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
PARAFFIN (UNII: I9O0E3H2ZE)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-137-14	57 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2016	09/30/2025
2	NDC:53329-137-44	113 g in 1 TUBE; Type 0: Not a Combination Product	01/06/2016	09/30/2025
3	NDC:53329-137-96	144 in 1 BOX	01/06/2016	10/31/2024
3	NDC:53329-137-16	5 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:53329-137-16	5 g in 1 PACKET; Type 0: Not a Combination Product	01/06/2016	10/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	01/06/2016	09/30/2025

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)

137 Remedy Phytoplex Z-Guard