FDA Label for Premier Value Zinc Oxide

View Indications, Usage & Precautions

Premier Value Zinc Oxide Product Label

The following document was submitted to the FDA by the labeler of this product Tai Guk Pharm. Co., Ltd.. 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, 20% ..............................................................................Skin protectant


Otc - Purpose



Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness
  • protects and dries the oozing and weeping of poison ivy, poison oak and poison sumac
  • helps prevent and temporarily protect chafed, chapped, cracked or windburned skin and lips

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use over deep or puncture wounds, infections or lacerations


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if condition worsens or does not improve within 7 days


Otc - 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.


Indications & Usage



Directions

  • change wet and soiled diapers promptly, cleanse the diaper area, and 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

Storage And Handling



Other information

  • Lot No. and Exp. Date: see box or see crimp of tube
  • store at 20o to 25oC (68o to 77oF)

Inactive Ingredient



Inactive ingredients

White petrolatum, talc, purified lanolin, liquid paraffin, triethanolamine, aloe vera gel, tocopherol acetate, butylated hydroxyloluene, methyl parahydroxybenzoate, purified water


Dosage & Administration



Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd., Suite 101

Boca Raton, FL 33431


Package Label.Principal Display Panel



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