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
Description

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

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

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

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

For external use only

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

Other Information
  • store at 15°C-30°C (59°F-86°F)
Active Ingredients

White petrolatum 49% w/w

Zinc oxide 15% w/w

Inactive Ingredients

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

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

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

Skin protectant

Warnings

For external use only

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

Other Information (Other information)
  • store at 15°C-30°C (59°F-86°F)
Active Ingredients (Active ingredients)

White petrolatum 49% w/w

Zinc oxide 15% w/w

Inactive Ingredients (Inactive ingredients)

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

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