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  5. Label Information: Astonea Skin Protectant

FDA Label for Astonea Skin Protectant

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF:
    7. KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS:
    9. OTHER INFORMATION:
    10. INACTIVE INGREDIENTS:
    11. PACKAGE LABELING:

Astonea Skin Protectant Product Label

The following document was submitted to the FDA by the labeler of this product Astonea Labs 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.

Active Ingredient



Zinc Oxide (1.8% w/w)


Purpose



Skin Protectant


Uses:



  • Helps treat and prevent diaper rash, incontinence or exposure to feces and urine
  • Protects Skin against irritation due to such rash and
  • Helps protect skin from exposure to wetness

Warnings:



For external use only


When Using This Product



  • Avoid contact with eyes
  • If eye contact occurs, flush with water

Stop Use And Ask A Doctor If:



  • Condition worsens or does not improve within seven days

Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center right away

Directions:



  • Change wet or solied diapers promptly
  • Clean diaper area with a mild cleanser, paying special attention to the perinium, buttocks, lower abdomen and inner thighs
  • Allow to dry
  • Apply to affected area as often as necessary or with each diaper change, especially at bedtime or any time when exposure to soiled diapers may be prolonged

Other Information:



  • Store at room temperature 15° - 30°C (59° - 86°F)
  • Avoid excessive heat

Inactive Ingredients:



Aloe Barbadensis Gel, Alpha-Tocopherol(Vitamin E), Cetostearyl Alcohol, Cholecalciferol (Vitamin D), FD&C Yellow No. 5, FD&C Yellow No. 6, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Lanolin, Lavender, Mineral Oil, Paraffin, Phenoxyethanol, Sodium Benzoate, Sodium Laureth-3 Sulfate, Vitamin A Palmitate, Water.


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