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  5. Label Information: Zinc Oxide And Dimethicone With Dimethicone

FDA Label for Zinc Oxide And Dimethicone With Dimethicone

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE:
    3. WARNINGS:
    4. DOSAGE AND ADMINISTRATION:
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. STOP USE IF
    8. INDICATIONS AND USAGE
    9. DO NOT USE
    10. KEEP OUT OF REACH OF CHILDREN
    11. PRINCIPAL DISPLAY PANEL

Zinc Oxide And Dimethicone With Dimethicone Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient        Purpose
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant


Purpose:



  • Helps treat and prevent diaper rash.
  • Dries the oozing and weeping of
  • poison ivy
  • poison oak
  • poison sumac


Warnings:



For external use only


Dosage And Administration:



For diaper rash

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • Apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

    • For poison ivy, oak and sumac

    • apply ointment liberally as often as needed

Other Information



  • Do not use if seal is punctured or not visible
  • store at room temperature 15°-30° C (59°-86° F)
  • avoid excessive heat

Inactive Ingredients



Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil


Stop Use If



  • conditions worsen
  • symptoms last more than 7 days or clear up and occur in a few days, consult a physician
  • over large areas of the body
  • if you are allergic to these ingredients

Indications And Usage



Indications are for diaper rash and general skin protectant.


Do Not Use



  • deep or puncture wounds
  • animal bites
  • serious burns

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.

Principal Display Panel



GalShield with Dimethicone

GalShield D.jpg


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