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

Purpose

Skin protectant

Description

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


Medication Information

Warnings

for external use only

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
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
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

Description

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

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

Warnings

for external use only

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
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
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

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