Astonea Xero

Astonea Xero
SPL v3
SPL
SPL Set ID e69ab651-9f37-8cb8-e053-2a95a90a88e3
Route
TOPICAL
Published
Effective Date 2022-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g) Dimethicone (1 g)
Inactive Ingredients
Alpha-tocopherol Acetate Petrolatum Light Mineral Oil Cholecalciferol Aloe Vera Leaf Clove Leaf Oil Lanolin Vitamin A Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-18
Description

Zinc Oxide 15% Dimethicone 1%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 15% Dimethicone 1%

Uses:
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

Purpose:

Skin Protectant

Warnings:

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.

Directions:
  • 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 anytime when exposure to wet diapers may be prolonged.
​warnings:
  • For external use only,
  • Avoid contact with eyes, In case of contact, flush thoroughly with water.
Other Information:
  • Store between 15-30 °C
Inactive Ingredients

Aloe vera Extract, Cholecalciferol, Eugenia Caryophyllus Flower Oil, Lanolin, Light Liquid Paraffin, Petrolatum, Retinyl Palmitate,Tocopheryl Acetate

​active Ingredients:

Zinc Oxide 15%

Dimethicone 1%

Label Principal Display Panel

Structured Label Content

Uses:
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

Purpose:

Skin Protectant

Warnings:

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.

Directions:
  • 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 anytime when exposure to wet diapers may be prolonged.
​warnings: (​Warnings:)
  • For external use only,
  • Avoid contact with eyes, In case of contact, flush thoroughly with water.
Other Information:
  • Store between 15-30 °C
Inactive Ingredients

Aloe vera Extract, Cholecalciferol, Eugenia Caryophyllus Flower Oil, Lanolin, Light Liquid Paraffin, Petrolatum, Retinyl Palmitate,Tocopheryl Acetate

​active Ingredients: (​Active Ingredients:)

Zinc Oxide 15%

Dimethicone 1%

Label Principal Display Panel

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:12.968823 · Updated: 2026-03-14T23:03:09.210552