Dimethicone Skin Protectant With Vitamin A,d,e, Zinc Oxide & Aloe Vera.

Dimethicone Skin Protectant With Vitamin A,d,e, Zinc Oxide & Aloe Vera.
SPL v3
SPL
SPL Set ID 2c7768a6-5859-74ca-e063-6394a90a8ef3
Route
TOPICAL
Published
Effective Date 2025-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (2 g) Dimethicone (1.8 g)
Inactive Ingredients
Trolamine White Petrolatum Cholecalciferol Cetostearyl Alcohol Glycerin Water Propylparaben Vitamin A Acetate Aloe Vera Leaf Alpha-tocopherol Ceteth-20 Lavender Oil Yellow 5 Methylparaben Cetyl Alcohol Lanolin Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

Zinc Oxide 2% Dimethicone 1.8%

Purpose

Diaper rash Skin Protectant


Medication Information

Purpose
  • Diaper rash
  • Skin Protectant
Description

Zinc Oxide 2% Dimethicone 1.8%

Uses
  • Use as a general skin protectant
  • Helps treat chafed skin associated with diaper & nappy rash
Warnings

For External Use Only.

Directions
  • 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 anytime when exposure to wet diapers may be prolonged.
  • For other uses: Apply as needed.
Other Information
  • Store at room temperature between 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if the seal is damaged.
Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), CETETH-20, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Yellow 5, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Petrolatum

Questions and Comments?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product:
  • Avoid contact with eyes
  • Do not use over large areas of the body
  • So not use if you are alergic to any of the ingredients
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 (1-800-222-1222) right away

Package/label Principal Display Panel

NDC: 84289-408-02

DIMETHICONE SKIN PROTECTANT BARRIER CREAM WITH

■ Vitamin A ■ Vitamin D ■ Vitamin E ■ Zinc Oxide ■ Aloe Vera

Enhanced Formula

Net Wt 4 oz. (113 g)

GOA/DRUGS/571


Structured Label Content

Uses
  • Use as a general skin protectant
  • Helps treat chafed skin associated with diaper & nappy rash
Purpose
  • Diaper rash
  • Skin Protectant
Warnings

For External Use Only.

Directions
  • 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 anytime when exposure to wet diapers may be prolonged.
  • For other uses: Apply as needed.
Other Information
  • Store at room temperature between 15º - 30ºC (59º - 86ºF)
  • Avoid excessive heat
  • Tamper evident. Do not use if the seal is damaged.
Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), CETETH-20, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Yellow 5, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Petrolatum

Questions and Comments?

(754)-200-8994 (Mon-Fri 8 AM to 4 PM EST)

When Using This Product: (When using this product:)
  • Avoid contact with eyes
  • Do not use over large areas of the body
  • So not use if you are alergic to any of the ingredients
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 (1-800-222-1222) right away

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC: 84289-408-02

DIMETHICONE SKIN PROTECTANT BARRIER CREAM WITH

■ Vitamin A ■ Vitamin D ■ Vitamin E ■ Zinc Oxide ■ Aloe Vera

Enhanced Formula

Net Wt 4 oz. (113 g)

GOA/DRUGS/571


Advanced Ingredient Data


Raw Label Data

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