768 Zinc Barrier Spray

768 Zinc Barrier Spray
SPL v3
SPL
SPL Set ID dae45414-7401-9536-e053-2a95a90a0a86
Route
TOPICAL
Published
Effective Date 2024-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (250 mg)
Inactive Ingredients
Caprylic/capric Triglyceride .alpha.-tocopherol Acetate Allantoin Aphanizomenon Flosaquae Cetyl Alcohol 1,3,3,3-tetrafluoropropene, (1z)- Clove Omega-3 Fatty Acids Propanediol Propylene Glycol Dicaprylate/dicaprate Butylene Glycol Yeast Glycerin Magnesium Sulfate Dimethicone Dicaprylyl Carbonate Sorbitan Sesquioleate Ethylhexylglycerin Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Hypnea Musciformis Diisopropyl Adipate Water Zea Mays (corn) Oil Polyhydroxystearic Acid (2300 Mw) Dehydroxanthan Gum Camellia Sinensis Leaf 7-dehydrocholesterol Astrocaryum Murumuru Seed Butter Peg-30 Dipolyhydroxystearate Zeolite A Kukui Nut Oil Gelidiella Acerosa Phenoxyethanol Polyamide-8 (4500 Mw) Polyglyceryl-3 Diisostearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Zinc oxide 25% w/w

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc oxide 25% w/w

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

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
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient

Zinc oxide 25% w/w

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

When Using This Product
  • do not get into eyes
Contents Under Pressure.

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

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

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.


Structured Label Content

Uses
  • helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps seal out wetness
Purpose

Skin Protectant

Warnings

For external use only

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
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Package Label

Active Ingredient (Active ingredient)

Zinc oxide 25% w/w

Other Information (Other information)
  • Protect from freezing, avoid excessive heat
  • Nonflammable
Inactive Ingredients (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

When Using This Product (When using this product)
  • do not get into eyes
Contents Under Pressure. (Contents under pressure.)

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

Manufacturing Information (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

Stop Use and Ask A Doctor (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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