endit zinc oxide skin protection

endit zinc oxide skin protection
SPL v2
SPL
SPL Set ID e60bb0da-3349-f8f9-e053-2a95a90a9051
Route
topical
Published
Effective Date 2022-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (200 mg)
Inactive Ingredients
boric acid starch, corn juniper tar lanolin resorcinol white petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-08-09

Purpose

Skin Protectant

Description

Zinc Oxide 20%


Medication Information

Warnings

For external use only.

Uses
  • Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urin, Protects chafed skin due to diaper rash and helps seal out wetness.
Purpose

Skin Protectant

Directions

For treatment of diaper rash:

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry. 
  • Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) may be prolonged.
Inactive Ingredients

Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

Description

Zinc Oxide 20%

Active Ingredient

Zinc Oxide 20%

Package Labeling:227g

Package Labeling:56.7 G

Package Labeling:113.4 G

When Using This Product 

do not get in eyes.

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.


Structured Label Content

Warnings

For external use only.

Uses
  • Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urin, Protects chafed skin due to diaper rash and helps seal out wetness.
Purpose

Skin Protectant

Directions

For treatment of diaper rash:

  • Change wet and soiled diapers promptly.
  • Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry. 
  • Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled diapers (feces, and/or urine) may be prolonged.
Inactive Ingredients

Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

Active Ingredient

Zinc Oxide 20%

Package Labeling:227g

Package Labeling:56.7 G (Package Labeling:56.7 g)

Package Labeling:113.4 G (Package Labeling:113.4 g)

When Using This Product  (When using this product )

do not get in eyes.

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.


Advanced Ingredient Data


Raw Label Data

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