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PREMIER VALUE ZINC OXIDE by TAI GUK PHARM. CO., LTD.

Dosage form: ointment
Ingredients: ZINC OXIDE 20g in 100g
Labeler: TAI GUK PHARM. CO., LTD.
NDC Code: 68169-0130

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active Ingredient                                                                              Purpose

Zinc oxide, 20% ..............................................................................Skin protectant

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

For external use only

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

When using this product avoid contact with the eyes

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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

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

Inactive ingredients

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

Distributed By:

Chain Drug Consortium, LLC.

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

Boca Raton, FL 33431

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PREMIER VALUE ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68169-0130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
TALC 
LANOLIN 
MINERAL OIL 
TROLAMINE 
ALOE VERA LEAF 
WATER 
Packaging
#Item CodePackage Description
1NDC:68169-0130-71 TUBE (TUBE) in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/08/2010
Labeler - TAI GUK PHARM. CO., LTD. (631101656)
Registrant - UNITED EXCHANGE CORP. (840130579)
Establishment
NameAddressID/FEIOperations
TAI GUK PHARM. CO., LTD.631101656manufacture

Revised: 11/2010
 
TAI GUK PHARM. CO., LTD.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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