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Zinc Oxide 20% by Pharmacy Value Alliance, LLC

Dosage form: ointment
Ingredients: ZINC OXIDE 0.2g in 1g
Labeler: Pharmacy Value Alliance, LLC
NDC Code: 68016-159

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.

Zinc Oxide Ointment 20%

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Skin Protectant

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash - 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

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For External Use Only

  • When using this product avoid contact with eyes
  • Stop use and ask a doctor if condition worsens or does not improve within 7 days. This may be a sign of a serious condition.

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 betime or anytime when exposure to wet diapers may be prolonged

Other Information
  • Store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive Ingredients

Mineral Oil, Petrolatum

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Packaging

ZINC OXIDE 20% 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-159
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:68016-159-021 TUBE in 1 BOX
157 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/19/2016
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 01/2018
 
Pharmacy Value Alliance, LLC

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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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