153 remedy specialized zinc oxide paste

153 remedy specialized zinc oxide paste
SPL v4
SPL
SPL Set ID 0073de92-585d-e01a-e063-6394a90a2ec2
Route
topical
Published
Effective Date 2023-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (150 mg) white petrolatum (490 mg)
Inactive Ingredients
hexyl laurate cetyl peg/ppg-10/1 dimethicone (hlb 5) polyglyceryl-4 isostearate glycerin stearic acid carboxymethylcellulose sodium water phenoxyethanol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-05-01
Purpose

Skin protectant

Description

White petrolatum 49% w/w Zinc oxide 15% w/w

Medication Information

Warnings

For external use only

Uses
  • temporarily protects minor cuts, scrapes, and burns
  • temporarily protects and helps relieve chapped or cracked skin
Purpose

Skin protectant

Directions
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
Other Information
  • store at 15°C-30°C (59°F-86°F)
Inactive Ingredients

carboxymethylcellulose sodium, cetyl PEG/PPG-10/1 dimethicone, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

Description

White petrolatum 49% w/w Zinc oxide 15% w/w

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

Active Ingredients

White petrolatum 49% w/w

Zinc oxide 15% w/w

When Using This Product
  • do not get into eyes
Manufacturing Information

www.medline.com

©2024 Medline and Medline Remedy

are registered trademarks of

Medline Industries, LP.

Made in India.

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: 325614

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again withinn 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

Warnings

For external use only

Uses
  • temporarily protects minor cuts, scrapes, and burns
  • temporarily protects and helps relieve chapped or cracked skin
Purpose

Skin protectant

Directions
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply liberally, as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
Other Information (Other information)
  • store at 15°C-30°C (59°F-86°F)
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, cetyl PEG/PPG-10/1 dimethicone, glycerin, hexyl laurate, phenoxyethanol, polyglyceryl-4 isostearate, stearic acid, water

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

Active Ingredients (Active ingredients)

White petrolatum 49% w/w

Zinc oxide 15% w/w

When Using This Product (When using this product)
  • do not get into eyes
Manufacturing Information

www.medline.com

©2024 Medline and Medline Remedy

are registered trademarks of

Medline Industries, LP.

Made in India.

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

1-800-MEDLINE

REF: 325614

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again withinn 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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:55.357691 · Updated: 2026-03-14T23:13:16.476899