176 Curad Zinc Oxide Cream Cur009814

176 Curad Zinc Oxide Cream Cur009814
SPL v4
SPL
SPL Set ID f162b1a8-65b3-13a8-e053-2a95a90a3f13
Route
TOPICAL
Published
Effective Date 2023-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g) Petrolatum (78 g)
Inactive Ingredients
Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Light Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-01

Description

White petrolatum 78% w/w, USP Zinc oxide 20% w/w, USP

Purpose

Skin protectant


Medication Information

Purpose
  • Skin protectant
Description

White petrolatum 78% w/w, USP Zinc oxide 20% w/w, USP

Uses
  • temporarily protects minor cuts, scrapes and burns
  • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • 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
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply cream 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
Other Information
  • store at controlled room temperature 68-77°F (20-25°C)
  • use only if packaging is intact
Inactive Ingredients

cetostearyl alcohol, light mineral oil, macrogol cetostearyl ether 20

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

©2023 CURAD and Medline are

registered trademarks of Medline Industries, LP

Made in India

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Visit www.curad.com or call 1-800-633-5463

REF: CUR009814

53329 176 14 Package Label

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last 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.

Active Ingredients (in Each Gram)
  • White petrolatum 78% w/w, USP
  • Zinc oxide 20% w/w, USP

Structured Label Content

Uses
  • temporarily protects minor cuts, scrapes and burns
  • helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin
  • 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
  • for skin protection: apply as needed
  • for diaper rash: change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply cream 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
Other Information (Other information)
  • store at controlled room temperature 68-77°F (20-25°C)
  • use only if packaging is intact
Inactive Ingredients (Inactive ingredients)

cetostearyl alcohol, light mineral oil, macrogol cetostearyl ether 20

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

©2023 CURAD and Medline are

registered trademarks of Medline Industries, LP

Made in India

Manufactured for Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Visit www.curad.com or call 1-800-633-5463

REF: CUR009814

53329 176 14 Package Label (53329-176-14 Package Label)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last 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.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))
  • White petrolatum 78% w/w, USP
  • Zinc oxide 20% w/w, USP

Advanced Ingredient Data


Raw Label Data

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