1199 Dynashield With Dimethicone Ndc 67777-408-03

1199 Dynashield With Dimethicone Ndc 67777-408-03
SPL v7
SPL
SPL Set ID b5dcf9e8-4689-4a08-ae73-3a859b4cbffe
Route
TOPICAL
Published
Effective Date 2014-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (1.8 g) Zinc Oxide (2 g)
Inactive Ingredients
White Petrolatum Methylparaben Vitamin A Acetate Lavender Oil Lanolin Ceteth-20 Mineral Oil Propylparaben Glycerin Cetyl Alcohol Cetostearyl Alcohol Cholecalciferol Alpha-tocopherol Aloe Vera Leaf Fd&c Yellow No. 5 Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-01

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 rash

• Dries the oozing and weeping of poison ivy, oak, and sumac

Label

DynaShield with Dimehticone

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 15 0 - 30 0 C (59 0 - 86 0 F)

• Avoid excessive heat

• Tamper evident. Do not use if seal is damaged.

Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Tartrazine, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Soft Paraffin

Questions and Comments?

1-888-396-2739, Monday - Friday 9AM-5PM EST

When Using This Product:

• Avoid contact with eyes

• Do not use over large areas of the body

• So not use if you are allergic 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.


Structured Label Content

Uses

• Use as a general skin protectant

• Helps treat chafed skin associated with diaper rash

• Dries the oozing and weeping of poison ivy, oak, and sumac

Label

DynaShield with Dimehticone

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 15 0 - 30 0 C (59 0 - 86 0 F)

• Avoid excessive heat

• Tamper evident. Do not use if seal is damaged.

Active Ingredients

Zinc Oxide 2%

Dimethicone 1.8%

Inactive Ingredients

Aloe Vera Leaf, Alpha-Tocopherol (Vitamin E), Cetomacrogol 1000, Cetostearyl Alcohol, Cetyl Alcohol, Glycerin, Lanolin, Lavender Oil, Methylparaben, Mineral Oil, Propylparaben, Tartrazine, Trolamine, Vitamin A Acetate, Vitamin D3, Water, White Soft Paraffin

Questions and Comments?

1-888-396-2739, Monday - Friday 9AM-5PM 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 allergic 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.


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Raw Label Data

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