FDA Label for Zinc Oxide

View Indications, Usage & Precautions

Zinc Oxide Product Label

The following document was submitted to the FDA by the labeler of this product Galentic Pharma (india) Priva Te 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.

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Drug Facts

Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,
Gandhidham-370 230, Gujrat. India


• Active Ingredient



Zinc Oxide 20%


• Purpose



Skin Protectant


• Uses



Helps treat and prevent diaper rash

Protects chafed skin due to diaper rash and helps seal out wetness


• Warnings



For external use only.


Otc - When Using



  • When using this product
    • do not get into eyes

Otc - Stop Use



  • 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

Otc - Keep Out Of Reach Of Children



  • 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.


• Dosage & Administration



  • Change wet and soiled diapers promptly
  • Cleanse the diaper area
  • Allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

• Other Information



  • Store at 15° to 30° C (59° to 86° F)
  • Lot No. & Exp. Date: See box or crimp of tube

• Inactive Ingredient



Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin


Principal Display Panel - 28 G Tube Carton



Galentic

Zinc Oxide
Ointment
SKIN PROTECTANT

Helps Heal, Soothe &
Prevent Diaper Rash

NET WT.
1 OZ. (28g)


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