MEDLINE- zinc oxide spray

Medline by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Zinc oxide 25% w/w

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash. 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

• 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.

Contents under pressure.

Do not puncture or incinerate. Do not store at temperatures above 120°F.

Directions

• shake well before using
• for skin protection
• apply as needed
• for diaper rash
• change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

• Protect from freezing, avoid excessive heat
• Nonflammable

Inactive ingredients

aleurites moluccanus (kukui) seed oil, allantoin, aphanizomenon flos aquae extract, astrocaryum murumuru seed butter, butylene glycol, camellia sinensis (green tea) leaf extract, caprylic/capric triglyceride, cetyl alcohol, 7-dehydrocholesterol, dehydroxanthan gum, dicaprylyl carbonate, diisopropyl adipate, dimethicone, ethylhexylglycerin, eugenia caryophyllus (clove) flower extract, gelidiella acerosa (algae) extract, glycerin, hydrolyzed soy protein, hypnea musciformis (algae) extract, magnesium sulfate, PEG-30 dipolyhydroxystearate, phenoxyethanol, phospholipids, polyamide-8, polyglyceryl-3 diisostearate, polyhydroxystearic acid, propanediol, propylene glycol dicaprylate/dicaprate, sorbitan sesquioleate, tetrafluoropropene, tocopheryl acetate, water, yeast ferment extract, zea mays (corn) oil, zeolite

Manufacturing information

www.medline.com
©2023 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

Made in the USA of foreign and domestic materials.
Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

Package Label

INGREDIENTS AND APPEARANCE

MEDLINE 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-768
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
CETYL ALCOHOL (UNII: 936JST6JCN)
1,3,3,3-TETRAFLUOROPROPENE, (1Z)- (UNII: XXV68QSS1E)
CLOVE (UNII: K48IKT5321)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PROPANEDIOL (UNII: 5965N8W85T)
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
YEAST (UNII: 3NY3SM6B8U)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNESIUM SULFATE (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
HYPNEA MUSCIFORMIS (UNII: W6FF9R1FJV)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
WATER (UNII: 059QF0KO0R)
ZEA MAYS (CORN) OIL (UNII: 8470G57WFM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ZEOLITE A (UNII: Y3NG9WF08W)
KUKUI NUT OIL (UNII: TP11QR7B8R)
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-768-55	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/01/2023

Labeler - Medline Industries, LP (025460908)

Registrant - Medline Industries, LP (025460908)